Boehringer Mannheim Corp.
FDA 510(k) medical device clearances.
Clearances by Boehringer Mannheim Corp. — page 2
101–200 of 340- K963182 — ELECSYS CALCHECK CK-MB
- K962508 — ELECSYS T3
- K960800 — CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)
- K961491 — ELECSYS TSH ASSAY
- K962573 — ELECSYS PRECICONTROL TSH
- K962575 — ELECSYS PRECICONTROL CARDIAC
- K961462 — CEDIA THEOPHYLLINE ASSAY
- K961481 — ELECSYS 2010 ANALYZER
- K961490 — ELECSYS T4 ASSAY
- K961659 — CEDIA CORE TDM MULTI-CAL
- K961487 — ELECSYS HCG ASSAY
- K961488 — ELECSYS T-UPTAKE ASSAY
- K961489 — ELECSYS FT4 ASSAY
- K961500 — ELECSYS TROPONIN T
- K961501 — ELECSYS CK-MB
- K944459 — ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM
- K944458 — ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
- K954496 — FRONTLINE COCAINE
- K954497 — FRONTLINE CANNABIS
- K954498 — FRONTLINE OPIATES
- K954833 — ACCU-CHEK ADVANTAGE TEST STRIPS
- K955868 — BOEHRINGER MANNHEIM CARDIAC T TROPNIN T
- K955906 — BOEHRINGER MANNHEIM IGG ASSAY
- K955907 — BOEHRINGER MANNHEIM IGA ASSAY
- K955908 — BOEHRINGER MANNHEIM IGM ASSAY
- K954608 — CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH
- K954807 — CEDIA T UPTAKE ASSAY
- K952625 — COAGUCHEK SYSTEM
- K952875 — ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS
- K952478 — BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY
- K954346 — CHEMSTRIP MICRAL URINE TEST STRIPS
- K954024 — CHEMSTRIP CRITERION URINE ANALYZER
- K953239 — BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER
- K951887 — ADVANTAGE TEST STRIPS
- K952839 — BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY
- K951331 — ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR
- K952127 — BOEHRINGER MANNHEIM CHOLESTEROL ASSAY
- K942884 — COAGUCHEK SYSTEM
- K932950 — TINA-QUANT MICROALBUMIN
- K933461 — BOEHRINGER MANNHEIM BICARBONATE ASSAY
- K943592 — CHEMSTRIP MINI UA URINE ANALYZER
- K934070 — TINA-QUANT HEMOGLOBIN A1C
- K942364 — HITACHI 914 ANALYZER
- K924392 — CARDIAC T ELISA TROPONIN-T
- K931258 — SOFTTOUCH II LANCET DEVICE
- K934064 — REFLOTRON HEMOGLOBIN TEST TABS
- K932778 — BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER
- K933589 — BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY
- K934042 — CHEMSTRIP SUPER UA URINE ANALYZER
- K930979 — ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM
- K930454 — BOEHRINGER MANNHEIM COAGUCHEK SYSTEM
- K931602 — CHEMSTRIP URINE ANALYZER
- K930621 — TINA-QUANT CRP
- K923048 — ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM
- K924475 — ACCUDATA GLUCOSE TEST STATION
- K921661 — BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER
- K921087 — CHEMSTRIP URINE ANALYZER
- K915195 — ENZYMUN-TEST TSH
- K915194 — CEDIA T4
- K913614 — FRUCTOSAMINE ABG21 TEST SYSTEM
- K913162 — ENZYMUN-TEST ESTRADIOL
- K913615 — URINARY/CSF PROTEIN
- K912212 — PROACT CHOLESTEROL SYSTEMS
- K913105 — REFLOTRON CREATININE TEST TABS
- K912441 — LINEARITY TEST KITS
- K912647 — ISE/CI-
- K912648 — ISE/NA+
- K912649 — ISE/K+
- K904752 — CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS
- K910683 — ENZYMUN-TEST PROGESTERONE
- K904033 — REFLOTRON POTASSIUM TEST TABS
- K904292 — ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM
- K904168 — ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM
- K904102 — REFLOTRON CREATINE KINASE TEST TABS
- K903573 — REFLOTRON CREATININE TEST TABS
- K902220 — PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL
- K903194 — REDITEST STREP A TEST KIT
- K902568 — REFLOTRON HDL CHOLESTEROL TEST TABS
- K902569 — PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF
- K902536 — PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM
- K902573 — PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM
- K901216 — ENZYMUN TEST(R) DIGOXIN
- K900883 — ENZYMUN TEST(R) FT4 (FREE THYROXINE)
- K900485 — ENZYMUN TEST(R) CORTISOL
- K901003 — BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER
- K901346 — ES 300 IMMUNOASSAY SYSTEM
- K900277 — ENZYMUN TEST(R) TSH-S
- K900779 — ENZYMUN TEST(R) LH
- K901135 — ENZYMUN TEST(R) INSULIN
- K900695 — ENZYMUN TEST(R) PROLACTIN
- K901086 — ENZYMUN TEST(R) T4 (TOTAL THYROXINE)
- K900763 — ENZYMUN TEST(R) FSH
- K896991 — ENZYMUN TEST(R) TBK
- K896900 — ENZYMUN TEST R T3
- K896901 — ENZYMUN TEST R HCG
- K900107 — LD-1
- K896454 — CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
- K896902 — ENZYMUN TEST R IGE
- K895880 — PANCREATIC A-AMYLASE EPS
- K895666 — BUN (KINETIC)
Data sourced from openFDA. This site is unofficial and independent of the FDA.