# Boehringer Mannheim Corp.

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 341 (1976–1999): 340 510(k) clearances and 1 original PMA approval
- Product codes: JJX (24), CGA (17), JJY (17), JJE (16), LFR (9), JIX (8), CHH (7), CDT (6), KQO (6), MMI (6), LTJ (5), KNK (5)
- Predicates its devices cite: 89 (38 its own); citations of its devices by later devices: 203 (38 its own)
- Recalls linked to its devices: 77 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tosoh Medics, Inc.: 14 (https://510kreport.com/company/tosoh-medics)
- Microgenics Corp.: 12 (https://510kreport.com/company/microgenics)
- Abbott Laboratories: 9 (https://510kreport.com/company/abbott-laboratories)
- Behring Diagnostics, Inc.: 4 (https://510kreport.com/company/behring-diagnostics)
- Bio-Rad: 2 (https://510kreport.com/company/bio-rad)
- Bio-Analytics Laboratories, Inc.: 1 (https://510kreport.com/company/bio-analytics-laboratories)
- Cortecs, Ltd.: 1 (https://510kreport.com/company/cortecs)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)

## Firms that cite its devices most
- Roche Diagnostics Corp.: 65 (https://510kreport.com/company/roche-diagnostics)
- Abbott Laboratories: 31 (https://510kreport.com/company/abbott-laboratories)
- Roche Diagnostic Systems, Inc.: 10 (https://510kreport.com/company/roche-diagnostic-systems)
- Medisense, Inc.: 4 (https://510kreport.com/company/medisense)
- Microgenics Corp.: 3 (https://510kreport.com/company/microgenics)
- Polymer Technology Systems, Inc.: 3 (https://510kreport.com/company/polymer-technology-systems)
- DiaSorin, Inc.: 3 (https://510kreport.com/company/diasorin)
- Abbott Diabetes Care, Inc.: 3 (https://510kreport.com/company/abbott-diabetes-care)

## Its most-cited devices
- K963147: Elecsys Calcheck TSH (1996), cited by 8
- K934070: Tina-Quant Hemoglobin A1C (1994), cited by 6
- K811194: Hitachi 705 Automatic Blood Chemistry (1981), cited by 5
- K872494: Hitachi 717 Chemistry Analyzer (1987), cited by 5
- K961491: Elecsys TSH Assay (1996), cited by 5
- K953239: Boehringer Mannheim/Hitachi 917 Analyzer (1995), cited by 5

## Recent decisions
- K984326: Elecys Ige Assay (Feb 8, 1999)
- K983047: Accu-Chek HQ System (Feb 5, 1999)
- K984419: Elecsys Ige Calcheck (Feb 2, 1999)
- K984425: Modification of Preciset Serum Proteins Calibrator (Jan 20, 1999)
- K984372: Elecsys Calcheck Troponin T (Dec 14, 1998)
- K984105: Elecsys Troponin T Stat Test (Dec 8, 1998)
- K983503: Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog Number 1730347 (Dec 1, 1998)
- K983469: Preciset Serum Proteins Calibrator (Nov 25, 1998)

Source page: https://510kreport.com/company/boehringer-mannheim