The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Diagnostics Acs:180 And Advia Centaur Troponin I Assay.
| Device ID | K993309 |
| 510k Number | K993309 |
| Device Name: | BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | BAYER CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Contact | William J Pignato |
| Correspondent | William J Pignato BAYER CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-04 |
| Decision Date | 1999-12-06 |
| Summary: | summary |