Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Boehringer Mannheim Corp. — Predicate Candidate Screening
340 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
155 days90th percentile
340clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K984326 | ELECYS IGE ASSAY | Boehringer Mannheim Corp. | 1999-02-08 | 67 | 0 |
| K983047 | ACCU-CHEK HQ SYSTEM | Boehringer Mannheim Corp. | 1999-02-05 | 157 | 1 |
| K984419 | ELECSYS IGE CALCHECK | Boehringer Mannheim Corp. | 1999-02-02 | 54 | 0 |
| K984425 | MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR | Boehringer Mannheim Corp. | 1999-01-20 | 40 | 0 |
| K984372 | ELECSYS CALCHECK TROPONIN T | Boehringer Mannheim Corp. | 1998-12-14 | 7 | 0 |
| K984105 | ELECSYS TROPONIN T STAT TEST | Boehringer Mannheim Corp. | 1998-12-08 | 21 | 2 |
| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC | Boehringer Mannheim Corp. | 1998-12-01 | 56 | 0 |
| K983469 | PRECISET SERUM PROTEINS CALIBRATOR | Boehringer Mannheim Corp. | 1998-11-25 | 55 | 0 |
| K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | Boehringer Mannheim Corp. | 1998-11-12 | 62 | 0 |
| K983510 | CHEMSTRIP 101 URINE ANALYZER | Boehringer Mannheim Corp. | 1998-10-27 | 20 | 0 |
| K982949 | ELECSYS PSA, MODEL 2010 | Boehringer Mannheim Corp. | 1998-10-27 | 67 | 0 |
| K982948 | ELECSYS PSA, MODEL # ELECSYS 1010 | Boehringer Mannheim Corp. | 1998-10-27 | 67 | 0 |
| K983416 | ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 | Boehringer Mannheim Corp. | 1998-10-21 | 22 | 0 |
| K980724 | TINAQUANT B 2-MICROGLOBULIN ASSAY | Boehringer Mannheim Corp. | 1998-10-16 | 234 | 0 |
| K983492 | BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC | Boehringer Mannheim Corp. | 1998-10-09 | 4 | 0 |
| K983176 | ELECSYS MYOGLOBIN STAT ASSAY | Boehringer Mannheim Corp. | 1998-09-24 | 14 | 0 |
| K983166 | ELECSYS CALCHECK MYOGLOBIN | Boehringer Mannheim Corp. | 1998-09-22 | 12 | 0 |
| K982089 | ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TE | Boehringer Mannheim Corp. | 1998-09-03 | 80 | 7 |
| K982002 | ACCU-CHEK COMFORT CURVE TEST STRIP | Boehringer Mannheim Corp. | 1998-09-02 | 86 | 1 |
| K982079 | ACCU-CHECK VOICEMATE | Boehringer Mannheim Corp. | 1998-08-28 | 74 | 3 |
| K982471 | B2-MICROGLOBULIN CONTROL SET SERUM | Boehringer Mannheim Corp. | 1998-08-06 | 21 | 0 |
| K981883 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DI | Boehringer Mannheim Corp. | 1998-07-07 | 39 | 0 |
| K980887 | ELECSYS CEA ON THE ELECSYS 1010 | Boehringer Mannheim Corp. | 1998-06-29 | 112 | 0 |
| K980746 | CEDIA DAU EDDP ASSAY | Boehringer Mannheim Corp. | 1998-05-26 | 89 | 0 |
| K980731 | ACCU-CHEK COMFORT CURVE TEST STRIPS | Boehringer Mannheim Corp. | 1998-05-22 | 86 | 0 |
| K981401 | BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS | Boehringer Mannheim Corp. | 1998-05-18 | 31 | 0 |
| K974491 | ACCU-CHEK A1C HEMOGLOBIN TEST | Boehringer Mannheim Corp. | 1998-05-13 | 166 | 0 |
| K980853 | CEDIA DAU MULTI-DRUG CALIBRATORS | Boehringer Mannheim Corp. | 1998-04-21 | 47 | 0 |
| K980240 | ELECSYS CA 125II ON THE ELECSYS 1010 | Boehringer Mannheim Corp. | 1998-03-25 | 61 | 0 |
| K972162 | ELECSYS CA 125 II | Boehringer Mannheim Corp. | 1998-03-18 | 282 | 0 |
| K973523 | ACCUSTAT H. PYLORI ONE STEP TEST | Boehringer Mannheim Corp. | 1998-03-03 | 167 | 0 |
| K974825 | BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS | Boehringer Mannheim Corp. | 1998-01-30 | 37 | 0 |
| K974733 | BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL | Boehringer Mannheim Corp. | 1998-01-26 | 39 | 1 |
| K974826 | BM PRECIPATH(R) HDL/LDL-C CONTROL | Boehringer Mannheim Corp. | 1998-01-22 | 29 | 0 |
| K972638 | TINA-QUANT PREALBUMIN | Boehringer Mannheim Corp. | 1998-01-09 | 178 | 0 |
| K972639 | TINA-QUANT HAPTOGLOBIN | Boehringer Mannheim Corp. | 1998-01-09 | 178 | 0 |
| K974569 | COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF | Boehringer Mannheim Corp. | 1998-01-09 | 32 | 5 |
| K972640 | TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY | Boehringer Mannheim Corp. | 1998-01-09 | 178 | 0 |
| K974189 | ELECSYS PSA (ON ELECSYS 1010) | Boehringer Mannheim Corp. | 1998-01-06 | 60 | 0 |
| K974421 | ELECSYS CK-MB STAT | Boehringer Mannheim Corp. | 1997-12-17 | 23 | 0 |
| K973662 | ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST | Boehringer Mannheim Corp. | 1997-12-15 | 81 | 2 |
| K974383 | ELECSYS CALCHECK VITAMIN B12 | Boehringer Mannheim Corp. | 1997-12-08 | 17 | 0 |
| K974384 | ELECSYS CALCHECK FOLATE | Boehringer Mannheim Corp. | 1997-12-08 | 17 | 0 |
| K973351 | ELECSYS AFP | Boehringer Mannheim Corp. | 1997-11-21 | 77 | 0 |
| K973702 | ELECSYS VITAMIN B12 ASSAY | Boehringer Mannheim Corp. | 1997-11-13 | 48 | 0 |
| K973674 | ELECSYS FOLATE | Boehringer Mannheim Corp. | 1997-11-12 | 47 | 0 |
| K973973 | ELECSYS CALLCHECK DIGOXIN | Boehringer Mannheim Corp. | 1997-11-04 | 15 | 0 |
| K973112 | ELECSYS DIGOXIN | Boehringer Mannheim Corp. | 1997-10-10 | 51 | 0 |
| K972876 | GLUCOTREND BASIC SYSTEM | Boehringer Mannheim Corp. | 1997-10-09 | 66 | 0 |
| K973629 | PRECINORM RF, PRECIPATH RF | Boehringer Mannheim Corp. | 1997-10-07 | 13 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda