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Boehringer Mannheim Corp.

340 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ELECSYS CALCHECK TSH (K963147)Boehringer Mannheim Corp.1996-08-23
ELECSYS T3 (K962508)Boehringer Mannheim Corp.1996-08-15
CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) (K960800)Boehringer Mannheim Corp.1996-07-26
ELECSYS PRECICONTROL CARDIAC (K962575)Boehringer Mannheim Corp.1996-07-22
ELECSYS TSH ASSAY (K961491)Boehringer Mannheim Corp.1996-07-22
ELECSYS PRECICONTROL TSH (K962573)Boehringer Mannheim Corp.1996-07-22
CEDIA THEOPHYLLINE ASSAY (K961462)Boehringer Mannheim Corp.1996-06-27
ELECSYS 2010 ANALYZER (K961481)Boehringer Mannheim Corp.1996-06-14
ELECSYS T4 ASSAY (K961490)Boehringer Mannheim Corp.1996-06-13
CEDIA CORE TDM MULTI-CAL (K961659)Boehringer Mannheim Corp.1996-06-13
ELECSYS T-UPTAKE ASSAY (K961488)Boehringer Mannheim Corp.1996-06-12
ELECSYS HCG ASSAY (K961487)Boehringer Mannheim Corp.1996-06-12
ELECSYS CK-MB (K961501)Boehringer Mannheim Corp.1996-06-11
ELECSYS TROPONIN T (K961500)Boehringer Mannheim Corp.1996-06-11
ELECSYS FT4 ASSAY (K961489)Boehringer Mannheim Corp.1996-06-11
ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM (K944459)Boehringer Mannheim Corp.1996-04-17
FRONTLINE CANNABIS (K954497)Boehringer Mannheim Corp.1996-03-06
FRONTLINE OPIATES (K954498)Boehringer Mannheim Corp.1996-03-06
ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST (K944458)Boehringer Mannheim Corp.1996-03-06
FRONTLINE COCAINE (K954496)Boehringer Mannheim Corp.1996-03-06
ACCU-CHEK ADVANTAGE TEST STRIPS (K954833)Boehringer Mannheim Corp.1996-02-15
BOEHRINGER MANNHEIM CARDIAC T TROPNIN T (K955868)Boehringer Mannheim Corp.1996-02-14
BOEHRINGER MANNHEIM IGG ASSAY (K955906)Boehringer Mannheim Corp.1996-02-09
BOEHRINGER MANNHEIM IGM ASSAY (K955908)Boehringer Mannheim Corp.1996-02-09
BOEHRINGER MANNHEIM IGA ASSAY (K955907)Boehringer Mannheim Corp.1996-02-09
CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH (K954608)Boehringer Mannheim Corp.1995-12-26
CEDIA T UPTAKE ASSAY (K954807)Boehringer Mannheim Corp.1995-12-21
ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS (K952875)Boehringer Mannheim Corp.1995-11-21
COAGUCHEK SYSTEM (K952625)Boehringer Mannheim Corp.1995-11-21
BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY (K952478)Boehringer Mannheim Corp.1995-11-09
CHEMSTRIP MICRAL URINE TEST STRIPS (K954346)Boehringer Mannheim Corp.1995-10-26
CHEMSTRIP CRITERION URINE ANALYZER (K954024)Boehringer Mannheim Corp.1995-10-23
BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER (K953239)Boehringer Mannheim Corp.1995-09-25
ADVANTAGE TEST STRIPS (K951887)Boehringer Mannheim Corp.1995-08-24
BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY (K952839)Boehringer Mannheim Corp.1995-08-24
ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR (K951331)Boehringer Mannheim Corp.1995-08-11
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY (K952127)Boehringer Mannheim Corp.1995-07-20
COAGUCHEK SYSTEM (K942884)Boehringer Mannheim Corp.1995-05-11
TINA-QUANT MICROALBUMIN (K932950)Boehringer Mannheim Corp.1995-02-10
BOEHRINGER MANNHEIM BICARBONATE ASSAY (K933461)Boehringer Mannheim Corp.1994-12-05
CHEMSTRIP MINI UA URINE ANALYZER (K943592)Boehringer Mannheim Corp.1994-11-08
TINA-QUANT HEMOGLOBIN A1C (K934070)Boehringer Mannheim Corp.1994-10-11
HITACHI 914 ANALYZER (K942364)Boehringer Mannheim Corp.1994-10-04
CARDIAC T ELISA TROPONIN-T (K924392)Boehringer Mannheim Corp.1994-04-26
SOFTTOUCH II LANCET DEVICE (K931258)Boehringer Mannheim Corp.1994-02-10
REFLOTRON HEMOGLOBIN TEST TABS (K934064)Boehringer Mannheim Corp.1993-12-06
BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER (K932778)Boehringer Mannheim Corp.1993-11-17
BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY (K933589)Boehringer Mannheim Corp.1993-11-03
CHEMSTRIP SUPER UA URINE ANALYZER (K934042)Boehringer Mannheim Corp.1993-10-14
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM (K930979)Boehringer Mannheim Corp.1993-09-08
BOEHRINGER MANNHEIM COAGUCHEK SYSTEM (K930454)Boehringer Mannheim Corp.1993-08-05
CHEMSTRIP URINE ANALYZER (K931602)Boehringer Mannheim Corp.1993-06-15
TINA-QUANT CRP (K930621)Boehringer Mannheim Corp.1993-03-10
ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM (K923048)Boehringer Mannheim Corp.1992-10-14
ACCUDATA GLUCOSE TEST STATION (K924475)Boehringer Mannheim Corp.1992-10-13
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER (K921661)Boehringer Mannheim Corp.1992-06-30
CHEMSTRIP URINE ANALYZER (K921087)Boehringer Mannheim Corp.1992-03-24
ENZYMUN-TEST TSH (K915195)Boehringer Mannheim Corp.1992-02-14
CEDIA T4 (K915194)Boehringer Mannheim Corp.1991-12-09
FRUCTOSAMINE ABG21 TEST SYSTEM (K913614)Boehringer Mannheim Corp.1991-12-02
ENZYMUN-TEST ESTRADIOL (K913162)Boehringer Mannheim Corp.1991-09-27
URINARY/CSF PROTEIN (K913615)Boehringer Mannheim Corp.1991-09-13
PROACT CHOLESTEROL SYSTEMS (K912212)Boehringer Mannheim Corp.1991-08-28
REFLOTRON CREATININE TEST TABS (K913105)Boehringer Mannheim Corp.1991-08-12
LINEARITY TEST KITS (K912441)Boehringer Mannheim Corp.1991-07-17
ISE/CI- (K912647)Boehringer Mannheim Corp.1991-07-17
ISE/NA+ (K912648)Boehringer Mannheim Corp.1991-07-17
ISE/K+ (K912649)Boehringer Mannheim Corp.1991-07-15
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS (K904752)Boehringer Mannheim Corp.1991-04-12
ENZYMUN-TEST PROGESTERONE (K910683)Boehringer Mannheim Corp.1991-04-08
REFLOTRON POTASSIUM TEST TABS (K904033)Boehringer Mannheim Corp.1990-11-06
ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM (K904292)Boehringer Mannheim Corp.1990-10-22
ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM (K904168)Boehringer Mannheim Corp.1990-10-15
REFLOTRON CREATINE KINASE TEST TABS (K904102)Boehringer Mannheim Corp.1990-09-27
REFLOTRON CREATININE TEST TABS (K903573)Boehringer Mannheim Corp.1990-09-07
PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL (K902220)Boehringer Mannheim Corp.1990-09-05
REDITEST STREP A TEST KIT (K903194)Boehringer Mannheim Corp.1990-08-22
PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF (K902569)Boehringer Mannheim Corp.1990-08-09
REFLOTRON HDL CHOLESTEROL TEST TABS (K902568)Boehringer Mannheim Corp.1990-08-09
PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM (K902536)Boehringer Mannheim Corp.1990-07-10
PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM (K902573)Boehringer Mannheim Corp.1990-07-10
ENZYMUN TEST(R) DIGOXIN (K901216)Boehringer Mannheim Corp.1990-05-31
ENZYMUN TEST(R) FT4 (FREE THYROXINE) (K900883)Boehringer Mannheim Corp.1990-05-15
ENZYMUN TEST(R) CORTISOL (K900485)Boehringer Mannheim Corp.1990-05-02
BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER (K901003)Boehringer Mannheim Corp.1990-04-16
ES 300 IMMUNOASSAY SYSTEM (K901346)Boehringer Mannheim Corp.1990-04-16
ENZYMUN TEST(R) TSH-S (K900277)Boehringer Mannheim Corp.1990-04-11
ENZYMUN TEST(R) INSULIN (K901135)Boehringer Mannheim Corp.1990-04-03
ENZYMUN TEST(R) LH (K900779)Boehringer Mannheim Corp.1990-04-03
ENZYMUN TEST(R) T4 (TOTAL THYROXINE) (K901086)Boehringer Mannheim Corp.1990-03-30
ENZYMUN TEST(R) PROLACTIN (K900695)Boehringer Mannheim Corp.1990-03-30
ENZYMUN TEST(R) FSH (K900763)Boehringer Mannheim Corp.1990-03-15
ENZYMUN TEST(R) TBK (K896991)Boehringer Mannheim Corp.1990-03-01
ENZYMUN TEST R T3 (K896900)Boehringer Mannheim Corp.1990-02-08
ENZYMUN TEST R HCG (K896901)Boehringer Mannheim Corp.1990-02-08
LD-1 (K900107)Boehringer Mannheim Corp.1990-01-18
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS (K896454)Boehringer Mannheim Corp.1990-01-11
ENZYMUN TEST R IGE (K896902)Boehringer Mannheim Corp.1990-01-10
PANCREATIC A-AMYLASE EPS (K895880)Boehringer Mannheim Corp.1989-12-19
BUN (KINETIC) (K895666)Boehringer Mannheim Corp.1989-10-27
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