Bio-Rad
FDA 510(k) medical device clearances.
Clearances by Bio-Rad — page 2
101–200 of 319- K990282 — ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01
- K984594 — LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220
- K984604 — ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05
- K984625 — ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05
- K984477 — LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529
- K984626 — ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5
- K990161 — ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01
- K990162 — ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01
- K990149 — ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01
- K990150 — ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01
- K990017 — ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10
- K984319 — ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05
- K984327 — ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05
- K984462 — LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206
- K984464 — LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211
- K984470 — LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209
- K984473 — LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205
- K984475 — LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212
- K984476 — LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207
- K984478 — LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210
- K984479 — LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208
- K984396 — LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213
- K984397 — LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203
- K984398 — LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201
- K984399 — LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204
- K984400 — LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202
- K984268 — VARIANT II HEMOGLOBIN A1C PROGRAM
- K984325 — ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05
- K983807 — LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580
- K984318 — ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05
- K984323 — ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05
- K984324 — ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05
- K984225 — LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384
- K984071 — LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644
- K984070 — ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05
- K984073 — ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05
- K984072 — ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05
- K984074 — ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05
- K983578 — ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05
- K981590 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON
- K981532 — LYPHOCHEK IMMUNOASSAY PLUS CONTROL
- K980871 — LYPHOCHEK WHOLE BLOOD CONTROL
- K980556 — LIQUICHEK CARDIAC MARKERS CONTROL LT
- K973350 — BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST
- K972609 — VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
- K972024 — CODA AUTOMATED EIA ANALYZER
- K972174 — LYPHOCHEK REMEDI CONTROL
- K971952 — LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600)
- K971954 — LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)
- K963018 — BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS
- K971691 — LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3
- K970666 — LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL
- K964963 — LYPHOCHEK COAGULATION CONTROL
- K965171 — LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426)
- K961432 — RADIAS GALT TEST
- K963040 — MANUAL PHENYLALANINE TEST
- K961941 — LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363
- K960437 — RADIAS PHENYLALANINE TEST
- K960392 — CDM
- K961828 — LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)
- K960987 — LIQUICHEK RHEUMATOID FACTOR CONTROL
- K955355 — VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
- K955153 — LYPHOCHEK BENZO/TCA CONTROL-SET B
- K955116 — BENZODIAZEPINES BY REMEDI HS
- K955024 — LIQUICHEK ETHANOL/AMMONIA CONTROL
- K954048 — VARIANT HEMOGLOBINOPATHY PROGRAM
- K951321 — RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
- K952817 — BIO-RAD URINARY 5-HIAA BY HPLC
- K945651 — LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 3
- K941616 — VARIANT TOTAL GHB PROGRAM
- K941596 — REMEDI HS DRUG PROFILING SYSTEM
- K941990 — BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC
- K941994 — BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLC
- K946163 — RADIAS TOTAL T4 ENZYME IMMUNOASSAY
- K944212 — RADIAS RED CELL FOLATE IMMUNOASAY
- K935399 — RADIAS NEONATAL TSH ENZYME IMMUNOASSAY
- K942451 — BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM
- K941509 — RADIAS ANA SCREEN ENZYME IMMUNOASSAY
- K942209 — LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH
- K935119 — RADIAS 3RD GENERATION TSH IMMUNOASSAY
- K935613 — RADIAS MONOCLONAL HBA 1C ASSAY
- K935286 — QUANTAPHASE II B12/FOLATE
- K934357 — LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2
- K933571 — RADIAS FOLATE ENZYME IMMUNOASSAY
- K933314 — RADIAS FERRITIN ENZYME IMMUNOASSAY
- K933315 — RADIAS B12 ENZYME IMMUNOASSAY
- K931740 — COTUBE ESTRADIOL RADIOIMMUNOASSAY
- K933317 — LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2
- K922590 — BIO-PEN SRK II CALCULATOR
- K932643 — LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL
- K932076 — LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II
- K921443 — TIP & MEMBRANE ASSEMBLY
- K931061 — RADIAS TSH ENZYME IMMUNOASSAY
- K931110 — RADIAS FREE T4 ENZYME IMMUNOASSAY
- K930898 — RADIAS AUTOMATED IMMUNOASSAY SYSTEM
- K926469 — VARIANT(TM) HEMOGLOBIN A 1C PROGRAM
- K924122 — VARIANT BETA-THALASSEMIA SHORT PROGRAM
- K924813 — VARIANT SICKLE CELL SHORT PROGRAM
- K925151 — LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3
- K923578 — LIQUICHEK RHEUMATOID FACTOR CONTROL
Data sourced from openFDA. This site is unofficial and independent of the FDA.