Boehringer Mannheim Corp.
Boehringer Mannheim Corp. holds FDA 510(k) medical device clearances, first cleared 1976, most recent 1999.
Top product codes for Boehringer Mannheim Corp.
Recent clearances by Boehringer Mannheim Corp.
1–100 of 340- K984326 — ELECYS IGE ASSAY
- K983047 — ACCU-CHEK HQ SYSTEM
- K984419 — ELECSYS IGE CALCHECK
- K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR
- K984372 — ELECSYS CALCHECK TROPONIN T
- K984105 — ELECSYS TROPONIN T STAT TEST
- K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347
- K983469 — PRECISET SERUM PROTEINS CALIBRATOR
- K983185 — BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
- K982948 — ELECSYS PSA, MODEL # ELECSYS 1010
- K982949 — ELECSYS PSA, MODEL 2010
- K983510 — CHEMSTRIP 101 URINE ANALYZER
- K983416 — ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353
- K980724 — TINAQUANT B 2-MICROGLOBULIN ASSAY
- K983492 — BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC
- K983176 — ELECSYS MYOGLOBIN STAT ASSAY
- K983166 — ELECSYS CALCHECK MYOGLOBIN
- K982089 — ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS
- K982002 — ACCU-CHEK COMFORT CURVE TEST STRIP
- K982079 — ACCU-CHECK VOICEMATE
- K982471 — B2-MICROGLOBULIN CONTROL SET SERUM
- K981883 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844
- K980887 — ELECSYS CEA ON THE ELECSYS 1010
- K980746 — CEDIA DAU EDDP ASSAY
- K980731 — ACCU-CHEK COMFORT CURVE TEST STRIPS
- K981401 — BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS
- K974491 — ACCU-CHEK A1C HEMOGLOBIN TEST
- K980853 — CEDIA DAU MULTI-DRUG CALIBRATORS
- K980240 — ELECSYS CA 125II ON THE ELECSYS 1010
- K972162 — ELECSYS CA 125 II
- K973523 — ACCUSTAT H. PYLORI ONE STEP TEST
- K974825 — BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS
- K974733 — BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
- K974826 — BM PRECIPATH(R) HDL/LDL-C CONTROL
- K972638 — TINA-QUANT PREALBUMIN
- K972639 — TINA-QUANT HAPTOGLOBIN
- K972640 — TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY
- K974569 — COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
- K974189 — ELECSYS PSA (ON ELECSYS 1010)
- K974421 — ELECSYS CK-MB STAT
- K973662 — ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS
- K974383 — ELECSYS CALCHECK VITAMIN B12
- K974384 — ELECSYS CALCHECK FOLATE
- K973351 — ELECSYS AFP
- K973702 — ELECSYS VITAMIN B12 ASSAY
- K973674 — ELECSYS FOLATE
- K973973 — ELECSYS CALLCHECK DIGOXIN
- K973112 — ELECSYS DIGOXIN
- K972876 — GLUCOTREND BASIC SYSTEM
- K973629 — PRECINORM RF, PRECIPATH RF
- K973358 — MYOGLOBIN CONTROL SET
- K972963 — MODIFIED CEDIA DAU PCP ASSAY
- K972235 — PRECICONTROL TUMOR MARKER 1 AND 2
- K964282 — TINA-QUANT FERRITIN ASSAY
- K972513 — TINAQUANT MYOGLOBIN ASSAY
- K964351 — ELECSYS PSA ASSAY
- K972433 — CEDIA DIGOXIN CALIBRATORS
- K971060 — PRECINORM TDM CONTROLS
- K971379 — TINAQUANT RHEUMATOID FACTOR ASSAY
- K964368 — ELECSYS CEA ASSAY
- K971833 — ELECSYS FERRITIN
- K970883 — CEDIA DIGOXIN II
- K970881 — CEDIA DIGOXIN
- K962571 — COAGUCHEK PST SYSTEM
- K970984 — THE ELECSYS CALCHECK PROGESTERONE
- K964841 — ELECSYS PROGESTERONE ASSAY
- K965085 — ENZYMUN-TEST PSA
- K964889 — ELECSYS TESTOSTERONE ASSAY
- K970452 — ELECSYS CALCHECK CEA
- K970458 — ELECSYS CALCHECK PSA
- K970459 — ELECSYS CALCHECK CEA
- K965109 — ELECSYS ESTRADIOL ASSAY
- K964372 — CARDIAC T TROPONIN T RAPID ASSAY
- K970147 — ELECSYS CALCHECK PROLACTIN
- K970148 — ELECSYS CALCHECK ESTRADIOL
- K970146 — ELECSYS CALCHECK TESTOSTERONE
- K964694 — ELECSYS LH ASSAY
- K964748 — ELECSYS PROLACTIN ASSAY
- K965157 — CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1
- K963127 — ELECSYS FT3
- K964693 — ELECSYS FSH ASSAY
- K964829 — ELECSYS CALCHECK FSH
- K964830 — ELECSYS CALCHECK LH
- K962734 — CEDIA DAU BENZODIAZEPINE ASSAY
- K962760 — ENZYMUN-TEST FT3
- K963840 — CEDIA PHENYTOIN II ASSAY
- K962795 — CEDIA DAU OPIATE 2K ASSAY
- K962269 — CEDIA CARDIAC TDM MULTI-CALS
- K963306 — CEDIA N-ACETYLPROCAINAMIDE ASSAY
- K963213 — BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
- K963181 — ELECSYS CALCHECK T UPDATE
- K963191 — CEDIA ANTIBIOTIC TDM MULTI-CALS
- K963165 — ELECSYS CALCHECK HCG
- K962099 — CEDIA PROCAINAMIDE ASSAY
- K963163 — ELECSYS CALCHECK FT3
- K963164 — ELECSYS CALCHECK FT4
- K963167 — ELECYS CALCHECK T 3
- K963178 — ELECSYS CALCHECK T4
- K963143 — ELECSYS CALCHECK TROPONIN T
- K963147 — ELECSYS CALCHECK TSH
Data sourced from openFDA. This site is unofficial and independent of the FDA.