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319 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01 (K990282)Bio-Rad1999-03-09
ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05 (K984625)Bio-Rad1999-02-02
ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05 (K984604)Bio-Rad1999-02-02
LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 (K984594)Bio-Rad1999-02-02
LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529 (K984477)Bio-Rad1999-01-29
ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 (K984626)Bio-Rad1999-01-29
ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01 (K990162)Bio-Rad1999-01-28
ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01 (K990161)Bio-Rad1999-01-28
ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01 (K990150)Bio-Rad1999-01-26
ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01 (K990149)Bio-Rad1999-01-26
ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10 (K990017)Bio-Rad1999-01-25
LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 (K984473)Bio-Rad1998-12-22
ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05 (K984319)Bio-Rad1998-12-22
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 (K984479)Bio-Rad1998-12-22
LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 (K984476)Bio-Rad1998-12-22
LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 (K984470)Bio-Rad1998-12-22
LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 (K984478)Bio-Rad1998-12-22
ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 (K984327)Bio-Rad1998-12-22
LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211 (K984464)Bio-Rad1998-12-22
LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 (K984475)Bio-Rad1998-12-22
LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 (K984462)Bio-Rad1998-12-22
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202 (K984400)Bio-Rad1998-12-18
LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201 (K984398)Bio-Rad1998-12-18
LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203 (K984397)Bio-Rad1998-12-18
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204 (K984399)Bio-Rad1998-12-18
LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 (K984396)Bio-Rad1998-12-18
VARIANT II HEMOGLOBIN A1C PROGRAM (K984268)Bio-Rad1998-12-17
ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05 (K984325)Bio-Rad1998-12-17
LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580 (K983807)Bio-Rad1998-12-16
ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05 (K984318)Bio-Rad1998-12-15
ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05 (K984324)Bio-Rad1998-12-15
ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 (K984323)Bio-Rad1998-12-15
LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 (K984225)Bio-Rad1998-12-14
LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 (K984071)Bio-Rad1998-12-03
ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05 (K984070)Bio-Rad1998-11-25
ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05 (K984073)Bio-Rad1998-11-25
ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05 (K984072)Bio-Rad1998-11-24
ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05 (K984074)Bio-Rad1998-11-20
ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 (K983578)Bio-Rad1998-11-12
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON (K981590)Bio-Rad1998-06-10
LYPHOCHEK IMMUNOASSAY PLUS CONTROL (K981532)Bio-Rad1998-05-12
LYPHOCHEK WHOLE BLOOD CONTROL (K980871)Bio-Rad1998-04-06
LIQUICHEK CARDIAC MARKERS CONTROL LT (K980556)Bio-Rad1998-02-25
BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST (K973350)Bio-Rad1998-02-09
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM (K972609)Bio-Rad1997-08-06
CODA AUTOMATED EIA ANALYZER (K972024)Bio-Rad1997-07-30
LYPHOCHEK REMEDI CONTROL (K972174)Bio-Rad1997-06-24
LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) (K971952)Bio-Rad1997-06-16
LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398) (K971954)Bio-Rad1997-06-11
BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS (K963018)Bio-Rad1997-06-04
LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3 (K971691)Bio-Rad1997-05-30
LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL (K970666)Bio-Rad1997-03-10
LYPHOCHEK COAGULATION CONTROL (K964963)Bio-Rad1997-02-20
LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426) (K965171)Bio-Rad1997-01-13
RADIAS GALT TEST (K961432)Bio-Rad1996-10-28
MANUAL PHENYLALANINE TEST (K963040)Bio-Rad1996-10-01
LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363 (K961941)Bio-Rad1996-09-16
RADIAS PHENYLALANINE TEST (K960437)Bio-Rad1996-08-16
CDM (K960392)Bio-Rad1996-07-08
LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) (K961828)Bio-Rad1996-06-11
LIQUICHEK RHEUMATOID FACTOR CONTROL (K960987)Bio-Rad1996-06-04
VARIANT ALPHA-THALASSEMIA SHORT PROGRAM (K955355)Bio-Rad1996-04-26
LYPHOCHEK BENZO/TCA CONTROL-SET B (K955153)Bio-Rad1996-02-05
BENZODIAZEPINES BY REMEDI HS (K955116)Bio-Rad1996-01-30
LIQUICHEK ETHANOL/AMMONIA CONTROL (K955024)Bio-Rad1995-11-28
VARIANT HEMOGLOBINOPATHY PROGRAM (K954048)Bio-Rad1995-11-20
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY (K951321)Bio-Rad1995-08-24
BIO-RAD URINARY 5-HIAA BY HPLC (K952817)Bio-Rad1995-08-01
LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 3 (K945651)Bio-Rad1995-05-16
VARIANT TOTAL GHB PROGRAM (K941616)Bio-Rad1995-04-14
REMEDI HS DRUG PROFILING SYSTEM (K941596)Bio-Rad1995-03-27
BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC (K941990)Bio-Rad1995-03-20
BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLC (K941994)Bio-Rad1995-03-20
RADIAS TOTAL T4 ENZYME IMMUNOASSAY (K946163)Bio-Rad1995-02-22
RADIAS RED CELL FOLATE IMMUNOASAY (K944212)Bio-Rad1995-02-03
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY (K935399)Bio-Rad1994-12-19
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM (K942451)Bio-Rad1994-11-10
RADIAS ANA SCREEN ENZYME IMMUNOASSAY (K941509)Bio-Rad1994-06-30
LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH (K942209)Bio-Rad1994-06-16
RADIAS 3RD GENERATION TSH IMMUNOASSAY (K935119)Bio-Rad1994-04-06
RADIAS MONOCLONAL HBA 1C ASSAY (K935613)Bio-Rad1994-04-05
QUANTAPHASE II B12/FOLATE (K935286)Bio-Rad1994-02-18
LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2 (K934357)Bio-Rad1993-10-21
RADIAS FOLATE ENZYME IMMUNOASSAY (K933571)Bio-Rad1993-10-01
RADIAS FERRITIN ENZYME IMMUNOASSAY (K933314)Bio-Rad1993-09-08
RADIAS B12 ENZYME IMMUNOASSAY (K933315)Bio-Rad1993-08-25
COTUBE ESTRADIOL RADIOIMMUNOASSAY (K931740)Bio-Rad1993-08-16
LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2 (K933317)Bio-Rad1993-08-11
BIO-PEN SRK II CALCULATOR (K922590)Bio-Rad1993-08-03
LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL (K932643)Bio-Rad1993-07-08
LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II (K932076)Bio-Rad1993-06-29
TIP & MEMBRANE ASSEMBLY (K921443)Bio-Rad1993-06-22
RADIAS TSH ENZYME IMMUNOASSAY (K931061)Bio-Rad1993-06-16
RADIAS FREE T4 ENZYME IMMUNOASSAY (K931110)Bio-Rad1993-05-20
RADIAS AUTOMATED IMMUNOASSAY SYSTEM (K930898)Bio-Rad1993-04-21
VARIANT(TM) HEMOGLOBIN A 1C PROGRAM (K926469)Bio-Rad1993-03-29
VARIANT BETA-THALASSEMIA SHORT PROGRAM (K924122)Bio-Rad1993-03-11
VARIANT SICKLE CELL SHORT PROGRAM (K924813)Bio-Rad1993-01-14
LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3 (K925151)Bio-Rad1992-12-17
LIQUICHEK RHEUMATOID FACTOR CONTROL (K923578)Bio-Rad1992-10-06
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