Siemens Healthcare Diagnostics, Inc.
FDA 510(k) medical device clearances.
Clearances by Siemens Healthcare Diagnostics, Inc. — page 2
101–152 of 152- K133728 — DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
- K132739 — IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL
- K133067 — ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
- K133122 — IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM)
- K133124 — IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA
- K133128 — IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION
- K132664 — ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
- K131662 — IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
- K132249 — ADVIA CENTAUR FT4, ADVIA CENTAUR T4
- K131536 — IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
- K121576 — IMMULITE 2000 ANTI-CCP IGG ASSAY
- K130276 — DIMENSION EXL WITH LM SYSTEM
- K122534 — IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
- K123933 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
- K123046 — ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
- K121994 — DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
- K122398 — RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
- K122599 — ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
- K120681 — ADVIA CHEMISTRY GLUH_3 REAGENTS
- K121084 — LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
- K110874 — ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
- K112343 — TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS
- K112523 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K113373 — DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
- K110586 — ADVIA CENTAUR VITAMIN D TOTAL ASSAY
- K110736 — ADVIA CHEMISTRY FERRITIN (FRT) METHOD
- K111677 — MICROSCAN(R) MICROSTREP PLUS(R)
- K111205 — MICROSCAN (R) MICROSTREP PLUS (R) PANELS
- K111394 — MICROSCAN MICROSTEP
- K103548 — ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
- K102681 — ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
- K100375 — DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
- K093987 — IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6
- K102779 — EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C
- K103701 — ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
- K103836 — ENZYME II CALIBRATOR
- K103612 — DIMENSION VISA ENZ 2 CAL
- K090330 — DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
- K083339 — DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
- K082638 — ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
- K083373 — IMMULITE 2000 FREE T4
- K081857 — DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306
- K081789 — DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
- K082030 — DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
- K081299 — DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA
- K081992 — DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
- K081319 — DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
- K081294 — ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS
- K081716 — ADVIA CENTAUR HAVM ASSAY
- K081074 — DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691
- K081103 — LOCI THYROID CALIBRATOR WITH MODEL RC610
- K080578 — DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA
Data sourced from openFDA. This site is unofficial and independent of the FDA.