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Boehringer Mannheim Corp.

340 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ELECYS IGE ASSAY (K984326)Boehringer Mannheim Corp.1999-02-08
ACCU-CHEK HQ SYSTEM (K983047)Boehringer Mannheim Corp.1999-02-05
ELECSYS IGE CALCHECK (K984419)Boehringer Mannheim Corp.1999-02-02
MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR (K984425)Boehringer Mannheim Corp.1999-01-20
ELECSYS CALCHECK TROPONIN T (K984372)Boehringer Mannheim Corp.1998-12-14
ELECSYS TROPONIN T STAT TEST (K984105)Boehringer Mannheim Corp.1998-12-08
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 (K983503)Boehringer Mannheim Corp.1998-12-01
PRECISET SERUM PROTEINS CALIBRATOR (K983469)Boehringer Mannheim Corp.1998-11-25
BOEHRINGER MANNHEIM TINA-QUANT IGE TEST (K983185)Boehringer Mannheim Corp.1998-11-12
CHEMSTRIP 101 URINE ANALYZER (K983510)Boehringer Mannheim Corp.1998-10-27
ELECSYS PSA, MODEL 2010 (K982949)Boehringer Mannheim Corp.1998-10-27
ELECSYS PSA, MODEL # ELECSYS 1010 (K982948)Boehringer Mannheim Corp.1998-10-27
ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 (K983416)Boehringer Mannheim Corp.1998-10-21
TINAQUANT B 2-MICROGLOBULIN ASSAY (K980724)Boehringer Mannheim Corp.1998-10-16
BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC (K983492)Boehringer Mannheim Corp.1998-10-09
ELECSYS MYOGLOBIN STAT ASSAY (K983176)Boehringer Mannheim Corp.1998-09-24
ELECSYS CALCHECK MYOGLOBIN (K983166)Boehringer Mannheim Corp.1998-09-22
ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS (K982089)Boehringer Mannheim Corp.1998-09-03
ACCU-CHEK COMFORT CURVE TEST STRIP (K982002)Boehringer Mannheim Corp.1998-09-02
ACCU-CHECK VOICEMATE (K982079)Boehringer Mannheim Corp.1998-08-28
B2-MICROGLOBULIN CONTROL SET SERUM (K982471)Boehringer Mannheim Corp.1998-08-06
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 (K981883)Boehringer Mannheim Corp.1998-07-07
ELECSYS CEA ON THE ELECSYS 1010 (K980887)Boehringer Mannheim Corp.1998-06-29
CEDIA DAU EDDP ASSAY (K980746)Boehringer Mannheim Corp.1998-05-26
ACCU-CHEK COMFORT CURVE TEST STRIPS (K980731)Boehringer Mannheim Corp.1998-05-22
BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS (K981401)Boehringer Mannheim Corp.1998-05-18
ACCU-CHEK A1C HEMOGLOBIN TEST (K974491)Boehringer Mannheim Corp.1998-05-13
CEDIA DAU MULTI-DRUG CALIBRATORS (K980853)Boehringer Mannheim Corp.1998-04-21
ELECSYS CA 125II ON THE ELECSYS 1010 (K980240)Boehringer Mannheim Corp.1998-03-25
ELECSYS CA 125 II (K972162)Boehringer Mannheim Corp.1998-03-18
ACCUSTAT H. PYLORI ONE STEP TEST (K973523)Boehringer Mannheim Corp.1998-03-03
BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS (K974825)Boehringer Mannheim Corp.1998-01-30
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL (K974733)Boehringer Mannheim Corp.1998-01-26
BM PRECIPATH(R) HDL/LDL-C CONTROL (K974826)Boehringer Mannheim Corp.1998-01-22
TINA-QUANT PREALBUMIN (K972638)Boehringer Mannheim Corp.1998-01-09
TINA-QUANT HAPTOGLOBIN (K972639)Boehringer Mannheim Corp.1998-01-09
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING (K974569)Boehringer Mannheim Corp.1998-01-09
TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY (K972640)Boehringer Mannheim Corp.1998-01-09
ELECSYS PSA (ON ELECSYS 1010) (K974189)Boehringer Mannheim Corp.1998-01-06
ELECSYS CK-MB STAT (K974421)Boehringer Mannheim Corp.1997-12-17
ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS (K973662)Boehringer Mannheim Corp.1997-12-15
ELECSYS CALCHECK VITAMIN B12 (K974383)Boehringer Mannheim Corp.1997-12-08
ELECSYS CALCHECK FOLATE (K974384)Boehringer Mannheim Corp.1997-12-08
ELECSYS AFP (K973351)Boehringer Mannheim Corp.1997-11-21
ELECSYS VITAMIN B12 ASSAY (K973702)Boehringer Mannheim Corp.1997-11-13
ELECSYS FOLATE (K973674)Boehringer Mannheim Corp.1997-11-12
ELECSYS CALLCHECK DIGOXIN (K973973)Boehringer Mannheim Corp.1997-11-04
ELECSYS DIGOXIN (K973112)Boehringer Mannheim Corp.1997-10-10
GLUCOTREND BASIC SYSTEM (K972876)Boehringer Mannheim Corp.1997-10-09
PRECINORM RF, PRECIPATH RF (K973629)Boehringer Mannheim Corp.1997-10-07
MYOGLOBIN CONTROL SET (K973358)Boehringer Mannheim Corp.1997-10-06
MODIFIED CEDIA DAU PCP ASSAY (K972963)Boehringer Mannheim Corp.1997-09-22
PRECICONTROL TUMOR MARKER 1 AND 2 (K972235)Boehringer Mannheim Corp.1997-08-12
TINA-QUANT FERRITIN ASSAY (K964282)Boehringer Mannheim Corp.1997-07-30
TINAQUANT MYOGLOBIN ASSAY (K972513)Boehringer Mannheim Corp.1997-07-28
ELECSYS PSA ASSAY (K964351)Boehringer Mannheim Corp.1997-07-25
CEDIA DIGOXIN CALIBRATORS (K972433)Boehringer Mannheim Corp.1997-07-24
PRECINORM TDM CONTROLS (K971060)Boehringer Mannheim Corp.1997-07-07
TINAQUANT RHEUMATOID FACTOR ASSAY (K971379)Boehringer Mannheim Corp.1997-06-17
ELECSYS CEA ASSAY (K964368)Boehringer Mannheim Corp.1997-06-16
ELECSYS FERRITIN (K971833)Boehringer Mannheim Corp.1997-06-02
CEDIA DIGOXIN II (K970883)Boehringer Mannheim Corp.1997-05-21
CEDIA DIGOXIN (K970881)Boehringer Mannheim Corp.1997-05-14
COAGUCHEK PST SYSTEM (K962571)Boehringer Mannheim Corp.1997-04-22
THE ELECSYS CALCHECK PROGESTERONE (K970984)Boehringer Mannheim Corp.1997-04-02
ELECSYS PROGESTERONE ASSAY (K964841)Boehringer Mannheim Corp.1997-03-24
ENZYMUN-TEST PSA (K965085)Boehringer Mannheim Corp.1997-03-19
ELECSYS TESTOSTERONE ASSAY (K964889)Boehringer Mannheim Corp.1997-03-18
ELECSYS CALCHECK CEA (K970459)Boehringer Mannheim Corp.1997-03-06
ELECSYS CALCHECK CEA (K970452)Boehringer Mannheim Corp.1997-03-06
ELECSYS CALCHECK PSA (K970458)Boehringer Mannheim Corp.1997-03-06
ELECSYS ESTRADIOL ASSAY (K965109)Boehringer Mannheim Corp.1997-02-18
CARDIAC T TROPONIN T RAPID ASSAY (K964372)Boehringer Mannheim Corp.1997-02-10
ELECSYS CALCHECK PROLACTIN (K970147)Boehringer Mannheim Corp.1997-02-10
ELECSYS CALCHECK ESTRADIOL (K970148)Boehringer Mannheim Corp.1997-02-10
ELECSYS CALCHECK TESTOSTERONE (K970146)Boehringer Mannheim Corp.1997-01-30
ELECSYS LH ASSAY (K964694)Boehringer Mannheim Corp.1997-01-24
ELECSYS PROLACTIN ASSAY (K964748)Boehringer Mannheim Corp.1997-01-21
CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1 (K965157)Boehringer Mannheim Corp.1997-01-17
ELECSYS FSH ASSAY (K964693)Boehringer Mannheim Corp.1996-12-16
ELECSYS CALCHECK FSH (K964829)Boehringer Mannheim Corp.1996-12-16
ELECSYS FT3 (K963127)Boehringer Mannheim Corp.1996-12-16
ELECSYS CALCHECK LH (K964830)Boehringer Mannheim Corp.1996-12-16
CEDIA DAU BENZODIAZEPINE ASSAY (K962734)Boehringer Mannheim Corp.1996-12-10
ENZYMUN-TEST FT3 (K962760)Boehringer Mannheim Corp.1996-11-29
CEDIA PHENYTOIN II ASSAY (K963840)Boehringer Mannheim Corp.1996-11-20
CEDIA DAU OPIATE 2K ASSAY (K962795)Boehringer Mannheim Corp.1996-10-30
CEDIA N-ACETYLPROCAINAMIDE ASSAY (K963306)Boehringer Mannheim Corp.1996-10-29
CEDIA CARDIAC TDM MULTI-CALS (K962269)Boehringer Mannheim Corp.1996-10-29
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL (K963213)Boehringer Mannheim Corp.1996-10-23
CEDIA ANTIBIOTIC TDM MULTI-CALS (K963191)Boehringer Mannheim Corp.1996-09-10
ELECSYS CALCHECK T UPDATE (K963181)Boehringer Mannheim Corp.1996-09-10
ELECSYS CALCHECK HCG (K963165)Boehringer Mannheim Corp.1996-08-30
ELECSYS CALCHECK FT4 (K963164)Boehringer Mannheim Corp.1996-08-27
CEDIA PROCAINAMIDE ASSAY (K962099)Boehringer Mannheim Corp.1996-08-27
ELECSYS CALCHECK FT3 (K963163)Boehringer Mannheim Corp.1996-08-27
ELECSYS CALCHECK T4 (K963178)Boehringer Mannheim Corp.1996-08-27
ELECYS CALCHECK T 3 (K963167)Boehringer Mannheim Corp.1996-08-27
ELECSYS CALCHECK TROPONIN T (K963143)Boehringer Mannheim Corp.1996-08-23
ELECSYS CALCHECK CK-MB (K963182)Boehringer Mannheim Corp.1996-08-23
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