Boehringer Mannheim Corp.
Boehringer Mannheim Corp. holds FDA 510(k) medical device clearances, first cleared 1976, most recent 1999.
Clearances by Boehringer Mannheim Corp. — page 3
201–300 of 340- K895665 — URIC ACID PAP
- K894207 — CK-MB/LD-1 CONTROL SYSTEM
- K892848 — PANCREATIC A-AMYLASE PNP
- K892838 — IRON SYSTEM PACK REAGENTS
- K891991 — BICARBONATE; SYSTEM PACK REAGENTS
- K882225 — -AMYLASE EPS
- K883817 — ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM
- K881908 — TRACER(TM) II BLOOD GLUCOSE SYSTEM
- K881677 — BUN (KINETIC)
- K880546 — TOTAL IRON BINDING CAPACITY (TIBC)
- K880610 — UNIMETER CALIBRATION KIT
- K874835 — PYRIDOXAL-5-PHOSPHATE TABLETS
- K874704 — REFLOTRON (R) AMYLASE
- K872818 — REFLOTRON BILIRUBIN
- K874230 — PRECINORM L
- K874435 — BICARBONATE
- K873363 — URIC ACID PAP
- K873049 — TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
- K872306 — SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA)
- K872494 — HITACHI 717 CHEMISTRY ANALYZER
- K871895 — TINA-QUANT [A] CRP
- K871896 — TINA-QUANT [A] TRANSFERRIN
- K871811 — SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)
- K871024 — PRECIMAT(R) C3
- K871027 — PRECINORM(R) PROTEIN
- K871022 — PRECIMAT(R) TRANSFERRIN
- K871023 — PRECIMAT(R) C4
- K871055 — PRECIMAT(R) CRP
- K863481 — MODIFICATION OF ACCU-CHEK II
- K870930 — TINA-QUANT(R) (A) C3
- K870931 — TINA-QUANT(R) (A) C4
- K870379 — ISE COMPENSATION SERA
- K870246 — REFLOTRON(R) AST (GOT)
- K860948 — TRACKER SYSTEM
- K864082 — REFLOTRON(R) ALT (GPT)
- K863822 — ENZYMUN-TEST(R) IGE
- K863352 — PRECIMAT (R) IGA, G, M
- K862762 — TINA-QUANT(R) IGM
- K862763 — TINA-QUANT(R) IGA
- K862764 — TINA-QUANT(R) IGG
- K862108 — ENZYMUN-TEST HCG
- K861792 — TWIN GOT-AST IFCC/GPT-ALT IFCC
- K861831 — REFLOTRON URIC ACID
- K861696 — ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704
- K862109 — ENZYMUN TEST TBG
- K861775 — TWIN BUN/GLUCOSE
- K861793 — TWIN TRIGLYCERIDES GPO/CHOLESTEROL
- K860647 — ES600 IMMUNOASSAY SYSTEM
- K860748 — HITACHI 736
- K860970 — PRECINORM IM AND PRECIPATH IM
- K860137 — ENZYMUN-TEST FERRITIN
- K854766 — CREATININE PAP
- K855225 — ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL
- K854243 — ES 22
- K854298 — IRON
- K854025 — HITACHI 704
- K852133 — REFLOTRON SYSTEM
- K851456 — ACCU-CHEK II
- K852136 — PRECINORM HB
- K850348 — UROTRON RL9
- K850667 — PERIDOCHROM TRIGLYCERIDES GPO
- K850017 — PRECINORM H & PRECIPATH H
- K850281 — CALCIUM
- K844426 — ALBUMIN BCP
- K844655 — PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE
- K844581 — 80 MG/DL GLUCOSE CONTROL
- K843283 — BOEHRINGER MANNHEIM DIAGNOSTICS ADAM
- K843569 — PRECISET AMMONIA
- K843087 — UNIVERSAL 2 S CENTRIFUGE
- K843088 — EBA 3 S CENTRIFUGE
- K842393 — BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE
- K840962 — REFLOCHECK-S
- K834271 — REFLOCHECK & GLUCOSE TEST STRIP SYS
- K833082 — REAGENT SET TRIGLYCERIDES GPO
- K833088 — SPIROMETER ISOLATION VALVE #8890
- K832251 — PRECISET CHOLESTEROL HIGH PERFORM
- K832158 — CHOLESTEROL HIGH PERFORMANCE-K
- K830356 — TITANIUM M.E. MULLER TYPE TOTAL HIP
- K823462 — SINGLE VIAL AMYLASE PNP TEST
- K823302 — CHOLESTEROL CHOD-PAP TEST
- K823196 — SPECIAL CONTROL SERUM FOR HDL-CHOLES
- K823213 — DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI
- K823087 — BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA
- K822441 — UNIMETER 330K
- K822445 — HCT CENTRIFUGE
- K821805 — PYRIDOXAL-5-PHOSPHATE STRIPES
- K821852 — DIAGNOSTICS HDL CHOLESTEROL PRECIPITANT
- K820888 — 8700 CLINICAL CHEM. ANALYZER
- K820596 — CYANMETHEMOGLOBIN TEST
- K820378 — LD-L TRIS SYSTEM PACK TEST
- K820118 — ELECTROLYTE ANALYZER ACCESSORY
- K812978 — URIC ACID SYSTEM PACK TEST
- K812303 — GLUCOSE-HK SYSTEM PACK TEST
- K812095 — ENXYMATIC CREATININE TEST
- K812290 — FUN-UV SYSTEM PACK TEST
- K811921 — HITACHI 705 CALIBRATOR
- K811832 — PRECINORM U & PRECIPATH U HUMAN SERUM
- K811553 — REAGENT SET TRIGLYCERIDES
- K811194 — HITACHI 705 AUTOMATIC BLOOD CHEMISTRY
- K810963 — BIO SET TM SUBSTRATE CALIBRATORS
Data sourced from openFDA. This site is unofficial and independent of the FDA.