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319 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
COTUBE PTH IRMA (K921949)Bio-Rad1992-09-02
CYLINDER OF GAS, CAN OF GAS (CC12F2) (K921617)Bio-Rad1992-08-05
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3 (K922046)Bio-Rad1992-07-10
LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2 (K921286)Bio-Rad1992-06-09
LYPHOCHEK(R) FRUCTOSAMINE CONTROL (K921089)Bio-Rad1992-04-29
LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2 (K914255)Bio-Rad1992-01-09
BIO-RAD TOTAL PROTEIN TEST KIT (K913315)Bio-Rad1992-01-02
LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM) (K914170)Bio-Rad1991-11-22
LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL (K911347)Bio-Rad1991-06-10
REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION (K911954)Bio-Rad1991-05-23
LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2 (K910829)Bio-Rad1991-04-03
NOVAPATH TSH ENZYME IMMUNOASSAY (K903311)Bio-Rad1990-09-07
LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2 (K903430)Bio-Rad1990-08-23
LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN (K901270)Bio-Rad1990-05-02
LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM (K901271)Bio-Rad1990-04-11
NOVAPATH MICROPLATE READER (K900776)Bio-Rad1990-04-03
NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM (K900775)Bio-Rad1990-03-09
BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC (K896744)Bio-Rad1990-02-23
HEMOGLOBIN A2 MICRO COLUMN TEST (K896168)Bio-Rad1990-01-18
LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3 (K895905)Bio-Rad1990-01-18
LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II (K891691)Bio-Rad1989-12-19
BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG. (K895816)Bio-Rad1989-12-07
BIO-RAD MODULAR AIR COMPRESSOR (K895575)Bio-Rad1989-10-31
PLASMA CATECHOLAMINES BY HPLC (K894966)Bio-Rad1989-10-25
LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II (K894078)Bio-Rad1989-08-11
LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM (K894252)Bio-Rad1989-08-01
LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3 (K891475)Bio-Rad1989-08-01
LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II (K891680)Bio-Rad1989-06-13
LIQUICHEK(R) SERUM ALCOHOL CONTROL; LEVELS 1,2 & 3 (K892004)Bio-Rad1989-04-21
COTUBE(TM) TSH IRMA (K890802)Bio-Rad1989-03-28
COTUBE LH IRMA ASSAY (K884498)Bio-Rad1988-12-22
LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN) (K884424)Bio-Rad1988-12-15
NOVAPATH SPECIMEN COLLECTION KIT (K884342)Bio-Rad1988-11-03
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II (K882486)Bio-Rad1988-10-25
COTUBE HCG IRMA TEST (K882155)Bio-Rad1988-08-08
DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY (K882222)Bio-Rad1988-08-01
BIO-RAD HEMOGLOBIN DETECTOR (K882051)Bio-Rad1988-08-01
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II (K882542)Bio-Rad1988-07-21
LYPHOCHEK URINE TOXICOLOGY CONTROL (K881989)Bio-Rad1988-06-20
LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL (K880145)Bio-Rad1988-06-20
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE (K881991)Bio-Rad1988-06-20
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW (K881990)Bio-Rad1988-06-20
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW (K880445)Bio-Rad1988-04-05
LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1) (K880496)Bio-Rad1988-03-16
LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2) (K880495)Bio-Rad1988-03-15
LYPHOCHEK SPINAL FLUID CONTROL (HUMAN) (K880494)Bio-Rad1988-03-03
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE (K880444)Bio-Rad1988-02-25
DETER. OF HEMOGLOBIN A2 USING THE DIAMAT (K875102)Bio-Rad1988-02-24
LYPHOCHEK WHOLE BLOOD CONTROL (K874731)Bio-Rad1988-02-18
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II (K874280)Bio-Rad1988-01-21
URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) (K873371)Bio-Rad1988-01-05
HVA & HOMOVANILLIC ACID BY HPLC METHOD (K873372)Bio-Rad1987-12-22
LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II (K872227)Bio-Rad1987-07-06
MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER (K871388)Bio-Rad1987-07-06
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT (K871860)Bio-Rad1987-05-29
DIGILAB MICRO ONE APPLANATION TONOMETER (K870121)Bio-Rad1987-02-20
DIGILAB MODEL 1500 PERIMETER (K870120)Bio-Rad1987-02-20
LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II (K865014)Bio-Rad1987-01-09
LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III (K864137)Bio-Rad1986-11-07
QUANTIMUNE(R) FERRITIN IRMA (K863487)Bio-Rad1986-10-01
DIGILAB MODULAR ONE-APPLANATION TONOMETER (K863217)Bio-Rad1986-09-24
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C) (K862371)Bio-Rad1986-09-16
LYPHOCHEK URINE TOXICOLOGY CONTROL (K861970)Bio-Rad1986-08-19
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL (K862185)Bio-Rad1986-08-04
LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II (K862186)Bio-Rad1986-07-01
VMA BY HPLC TEST (VANILMANDELIC ACID) (K861010)Bio-Rad1986-05-01
ECHOCLONAL HTSH IRMA (K860288)Bio-Rad1986-04-11
BIOGRAM APO A1/B (K860629)Bio-Rad1986-03-28
DIGILAB CAMBRIDGE PERIMETER (K860115)Bio-Rad1986-02-27
DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM (K851636)Bio-Rad1985-07-30
LYPHOCHEK DRUG FREE SERUM(HUMAN) (K852414)Bio-Rad1985-07-24
ECHOCLONAL HCG IRMA (K852201)Bio-Rad1985-06-28
DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU (K850191)Bio-Rad1985-03-04
LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN (K844125)Bio-Rad1985-01-08
TRIGLYCERIDES GPO REAGENT (K843552)Bio-Rad1984-09-26
LYPHOCHEK THERAPEUTIC DRUG CONTROL (K833794)Bio-Rad1984-01-24
QUANTAPHASE B-12-COBALMIN-FOLATE- (K833247)Bio-Rad1983-10-19
LYPHOCHEK SERUM REF. STANDARD-BOVINE (K832695)Bio-Rad1983-10-04
DIGILAB 350 THE KRAKAU PERIMETER (K832175)Bio-Rad1983-08-16
QUANTIGEN T & B CELL ASSAY (K831053)Bio-Rad1983-08-08
QUANTIMUNE HFSH RIA HUMAN FOLLICLE- (K831742)Bio-Rad1983-07-18
LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN (K831478)Bio-Rad1983-06-22
HEMOGLOBIN ALC BY COLUMN TEST (K830935)Bio-Rad1983-06-16
HEMOGLOBIN ALC BY COLUMN TEST (K822977)Bio-Rad1982-11-16
QUANTIMUNE HTSH IRMA (K822291)Bio-Rad1982-08-27
QUANTIMUNE HLH RIA (K821346)Bio-Rad1982-05-28
QUANTIMUNE ESTRIOL RIA (K820728)Bio-Rad1982-04-06
BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST (K811710)Bio-Rad1981-07-15
FLUOROMATIC THEOPHYLLINE FIA (K811856)Bio-Rad1981-07-10
QUANTAPHASE T-4 RIA (K811787)Bio-Rad1981-07-10
QUANTIMUNE ESTRIOL RIA (K811709)Bio-Rad1981-07-10
QUANTA PHASE VITAMIN B-12/FOLATE RAD (K811177)Bio-Rad1981-05-15
QUANTIMUNE FERRITIN IRMA (K810799)Bio-Rad1981-04-03
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM (K810302)Bio-Rad1981-02-25
QUANTIMUNE E3 RIA (K802944)Bio-Rad1980-12-22
QUANTIMUNE CORTISOL RIA CORTISOL RADIO- (K800045)Bio-Rad1980-01-23
FLUOROMATIC PHENOLBARBITAL FIA (K800090)Bio-Rad1980-01-23
FLUOROMATIC PHENYTOIN FIA (K792640)Bio-Rad1980-01-11
VMA BY COLUMN TEST (K791837)Bio-Rad1979-10-30
QUANTIMUNE GENTAMICIN RIA GENTAMICIN (K791770)Bio-Rad1979-10-17
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