Dade Behring, Inc.
FDA 510(k) medical device clearances.
Clearances by Dade Behring, Inc. — page 3
201–300 of 343- K022290 — PROTEIN S AC
- K020413 — MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML)
- K020979 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
- K020980 — DIMENSION TPSA CALIBRATOR, MODEL #RC459
- K020410 — MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML)
- K021381 — MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
- K020398 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)
- K020692 — EMIT 2000 VANCOMYCIN ASSAY
- K020724 — DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
- K020820 — MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME
- K020723 — DIMENSION ALDL CALIBRATOR, MODEL DC131
- K020822 — MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN
- K020845 — EMIT 2000 VANCOMYCIN CALIBRATORS
- K021037 — MICROSTREP PLUS PANEL WITH AMPICILLIN
- K020397 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-256 UG/ML)
- K020319 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML)
- K020441 — EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY
- K020142 — MICROSCAN SYNERGIES PLUS
- K020160 — DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN
- K020162 — DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN
- K020248 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML)
- K020328 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML)
- K020168 — MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML)
- K020173 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML)
- K020182 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML)
- K020185 — MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML)
- K020209 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML)
- K020246 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML)
- K020249 — MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)
- K013128 — N LATEX LP(A)
- K013155 — DADE THROMBOPLASTIN C PLUS
- K011852 — DIMENSION HAIC ASSAY, MODEL DF105
- K013114 — BCS SYSTEM
- K013126 — N LP(A) STANDARD SY
- K013130 — N LP(A) CONTROL SY
- K012470 — MODIFICATION TO N PROTEIN STANDARD SL
- K012233 — STRATUS CS TROPONIN I CALIBRATOR
- K012468 — MODIFICATION TO N/T PROTEIN CONTROL SL
- K010418 — DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
- K011665 — BCT SYSTEM
- K011235 — SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500
- K011112 — CYCLOSPORINE CALIBRATOR
- K010871 — TGL FLEX REAGENT CARTRIDGE
- K002885 — DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
- K011035 — DIMENSION DRUG CALIBRATOR, MODEL DC22B
- K011033 — DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
- K010494 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
- K010313 — DIMENSION CTNI FLEX REAGENT CARTRIDGE
- K010314 — DIMENSION CTNI CALIBRATOR
- K010206 — DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
- K003501 — N PROTEIN STANDARD UY CALIBRATOR
- K010061 — DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
- K003503 — N LATEX CYSTATIN C
- K003963 — DIMENSION PSA FLEX REAGENT CARTRIDGE
- K003870 — THROMBOREL S
- K010208 — DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
- K003419 — RCRP FLEX REAGENT CARTRIDGE
- K003696 — STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD
- K003209 — URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
- K002852 — N/T PROTEIN CONTROL SL
- K002731 — N LATEX B2-MICROGLOBULIN
- K002080 — BEHRING COAGULATION SYSTEM, MODEL BCS
- K002551 — EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL
- K002974 — EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL
- K002804 — N PROTEIN STANDARD SL
- K001647 — BN PROSPEC SYSTEM
- K002541 — PROTEIN C REAGENT
- K001645 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
- K001064 — BEHRING COAGULATION TIMER ANALYZER (BCT)
- K001067 — DADE BEHRING COAGULATION ANALYZER (BCT)
- K000973 — BEHRING COAGULATION SYSTEM (BCS)
- K001256 — CONTROL PLASMA N
- K001145 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
- K000649 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
- K000458 — URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
- K000460 — URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
- K000464 — URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
- K000467 — URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
- K000461 — URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
- K000462 — URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
- K000466 — URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
- K000459 — URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
- K994341 — FIBRINOGEN CALIBRATOR KIT
- K994291 — DIMENSION SPECIAL PROTEIN CALIBRATOR
- K994293 — DIMENSION C4 FLEX REAGENT CARTRIDGE
- K994296 — DIMENSION C3 FLEX REAGENT CARTRIDGE
- K994294 — DIMENSION TRNF FLEX REAGENT CARTRIDGE
- K992957 — ADVANCED D-DIMER
- K994115 — TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
- K994114 — DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR
- K992959 — BEHRING COAGULATION SYSTEM (BCS)
- K993299 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
- K993310 — APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH
- K993273 — N LATEX FERRITIN
- K993174 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
- K991385 — DADE BEHRING N HIGH SENSITIVITY CRP ASSAY
- K992423 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
- K992763 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
- K992321 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
- K991157 — N LATEX STFR REAGENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.