The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Cardiac T Troponin T Rapid Assay.
| Device ID | K964372 |
| 510k Number | K964372 |
| Device Name: | CARDIAC T TROPONIN T RAPID ASSAY |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | John D Stevens |
| Correspondent | John D Stevens BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-01 |
| Decision Date | 1997-02-10 |
| Summary: | summary |