K882795 is an FDA 510(k) clearance for the DADE(R) CK-MB IMMUNOASSAY CONTROL. This device is classified as a Enzyme Controls (assayed And Unassayed) (Class I - General Controls, product code JJT).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on August 29, 1988, 54 days after receiving the submission on July 6, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K882795 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1988 |
| Decision Date | August 29, 1988 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJT — Enzyme Controls (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |