Boehringer Mannheim Corp.
FDA 510(k) medical device clearances.
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.