K980528 is an FDA 510(k) clearance for the CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI). This device is classified as a Immunoassay Method, Troponin Subunit (Class II - Special Controls, product code MMI).
Submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on March 3, 1998, 20 days after receiving the submission on February 11, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K980528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 1998 |
| Decision Date | March 03, 1998 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | MMI — Immunoassay Method, Troponin Subunit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |