Company ยท US
Boehringer Mannheim Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1999. Name variants (Inc, Corp, punctuation) are merged.
340510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 24 |
| CGA | Glucose Oxidase, Glucose | 17 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 17 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 16 |
| LFR | Glucose Dehydrogenase, Glucose | 9 |
| JIX | Calibrator, Multi-Analyte Mixture | 8 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 7 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 6 |
| KQO | Automated Urinalysis System | 6 |
| MMI | Immunoassay Method, Troponin Subunit | 6 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 5 |
| JIS | Calibrator, Primary | 5 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 5 |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 5 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 4 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 4 |
| JFY | Enzymatic Method, Creatinine | 4 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 4 |
| KHS | Enzymatic, Carbon-Dioxide | 4 |
| KXT | Enzyme Immunoassay, Digoxin | 4 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 8, 1999 | K984326 | ELECYS IGE ASSAY Boehringer Mannheim Corp. | JHR |
| Feb 5, 1999 | K983047 | ACCU-CHEK HQ SYSTEM Boehringer Mannheim Corp. | LFR |
| Feb 2, 1999 | K984419 | ELECSYS IGE CALCHECK Boehringer Mannheim Corp. | JJY |
| Jan 20, 1999 | K984425 | MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR Boehringer Mannheim Corp. | JIX |
| Dec 14, 1998 | K984372 | ELECSYS CALCHECK TROPONIN T Boehringer Mannheim Corp. | JJY |
| Dec 8, 1998 | K984105 | ELECSYS TROPONIN T STAT TEST Boehringer Mannheim Corp. | MMI |
| Dec 1, 1998 | K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 Boehringer Mannheim Corp. | CEO |
| Nov 25, 1998 | K983469 | PRECISET SERUM PROTEINS CALIBRATOR Boehringer Mannheim Corp. | JIX |
| Nov 12, 1998 | K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST Boehringer Mannheim Corp. | DGC |
| Oct 27, 1998 | K983510 | CHEMSTRIP 101 URINE ANALYZER Boehringer Mannheim Corp. | KQO |
| Oct 27, 1998 | K982949 | ELECSYS PSA, MODEL 2010 Boehringer Mannheim Corp. | LTJ |
| Oct 27, 1998 | K982948 | ELECSYS PSA, MODEL # ELECSYS 1010 Boehringer Mannheim Corp. | LTJ |
| Oct 21, 1998 | K983416 | ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 Boehringer Mannheim Corp. | JGJ |
| Oct 16, 1998 | K980724 | TINAQUANT B 2-MICROGLOBULIN ASSAY Boehringer Mannheim Corp. | JZG |
| Oct 9, 1998 | K983492 | BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC Boehringer Mannheim Corp. | JJY |
| Sep 24, 1998 | K983176 | ELECSYS MYOGLOBIN STAT ASSAY Boehringer Mannheim Corp. | DDR |
| Sep 22, 1998 | K983166 | ELECSYS CALCHECK MYOGLOBIN Boehringer Mannheim Corp. | JJY |
| Sep 3, 1998 | K982089 | ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS Boehringer Mannheim Corp. | LFR |
| Sep 2, 1998 | K982002 | ACCU-CHEK COMFORT CURVE TEST STRIP Boehringer Mannheim Corp. | LFR |
| Aug 28, 1998 | K982079 | ACCU-CHECK VOICEMATE Boehringer Mannheim Corp. | LFR |
| Aug 6, 1998 | K982471 | B2-MICROGLOBULIN CONTROL SET SERUM Boehringer Mannheim Corp. | JJX |
| Jul 7, 1998 | K981883 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 Boehringer Mannheim Corp. | CIG |
| Jun 29, 1998 | K980887 | ELECSYS CEA ON THE ELECSYS 1010 Boehringer Mannheim Corp. | DHX |
| May 26, 1998 | K980746 | CEDIA DAU EDDP ASSAY Boehringer Mannheim Corp. | DJR |
| May 22, 1998 | K980731 | ACCU-CHEK COMFORT CURVE TEST STRIPS Boehringer Mannheim Corp. | LFR |
| May 18, 1998 | K981401 | BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS Boehringer Mannheim Corp. | JJY |
| May 13, 1998 | K974491 | ACCU-CHEK A1C HEMOGLOBIN TEST Boehringer Mannheim Corp. | LCP |
| Apr 21, 1998 | K980853 | CEDIA DAU MULTI-DRUG CALIBRATORS Boehringer Mannheim Corp. | DKB |
| Mar 25, 1998 | K980240 | ELECSYS CA 125II ON THE ELECSYS 1010 Boehringer Mannheim Corp. | LTK |
| Mar 18, 1998 | K972162 | ELECSYS CA 125 II Boehringer Mannheim Corp. | LTK |
| Mar 3, 1998 | K973523 | ACCUSTAT H. PYLORI ONE STEP TEST Boehringer Mannheim Corp. | LYR |
| Jan 30, 1998 | K974825 | BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS Boehringer Mannheim Corp. | JIX |
| Jan 26, 1998 | K974733 | BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL Boehringer Mannheim Corp. | LBR |
| Jan 22, 1998 | K974826 | BM PRECIPATH(R) HDL/LDL-C CONTROL Boehringer Mannheim Corp. | JJY |
| Jan 9, 1998 | K974569 | COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING Boehringer Mannheim Corp. | JPA |
| Jan 9, 1998 | K972640 | TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY Boehringer Mannheim Corp. | DEM |
| Jan 9, 1998 | K972639 | TINA-QUANT HAPTOGLOBIN Boehringer Mannheim Corp. | DAD |
| Jan 9, 1998 | K972638 | TINA-QUANT PREALBUMIN Boehringer Mannheim Corp. | JZJ |
| Jan 6, 1998 | K974189 | ELECSYS PSA (ON ELECSYS 1010) Boehringer Mannheim Corp. | LTJ |
| Dec 17, 1997 | K974421 | ELECSYS CK-MB STAT Boehringer Mannheim Corp. | JHY |
| Dec 15, 1997 | K973662 | ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS Boehringer Mannheim Corp. | LFR |
| Dec 8, 1997 | K974384 | ELECSYS CALCHECK FOLATE Boehringer Mannheim Corp. | JJY |
| Dec 8, 1997 | K974383 | ELECSYS CALCHECK VITAMIN B12 Boehringer Mannheim Corp. | JJX |
| Nov 21, 1997 | K973351 | ELECSYS AFP Boehringer Mannheim Corp. | LOJ |
| Nov 13, 1997 | K973702 | ELECSYS VITAMIN B12 ASSAY Boehringer Mannheim Corp. | CDD |
| Nov 12, 1997 | K973674 | ELECSYS FOLATE Boehringer Mannheim Corp. | CDD |
| Nov 4, 1997 | K973973 | ELECSYS CALLCHECK DIGOXIN Boehringer Mannheim Corp. | DMP |
| Oct 10, 1997 | K973112 | ELECSYS DIGOXIN Boehringer Mannheim Corp. | KXT |
| Oct 9, 1997 | K972876 | GLUCOTREND BASIC SYSTEM Boehringer Mannheim Corp. | LFR |
| Oct 7, 1997 | K973629 | PRECINORM RF, PRECIPATH RF Boehringer Mannheim Corp. | JJY |
Newest 50 of 340.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||