The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Chiron Diagnostics Acs:180 Troponin I Assay (ctni).
| Device ID | K980528 |
| 510k Number | K980528 |
| Device Name: | CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Contact | William J Pignato |
| Correspondent | William J Pignato CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-11 |
| Decision Date | 1998-03-03 |