K981474 is an FDA 510(k) clearance for the CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I). This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I - General Controls, product code JJY).
Submitted by Spectral Diagnostics, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on May 7, 1998, 13 days after receiving the submission on April 24, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K981474 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 1998 |
| Decision Date | May 07, 1998 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JJY — Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |