The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Troponin I Assay For The Bayer Immuno 1 System ( In Vitro Diagnostic System).
| Device ID | K993353 |
| 510k Number | K993353 |
| Device Name: | TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM) |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca Jr |
| Correspondent | Gabriel J Muraca Jr BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-05 |
| Decision Date | 1999-12-06 |
| Summary: | summary |