K851520 is an FDA 510(k) clearance for the CK/LD ISOENZYMES CONTROLS(HUMAN). This device is classified as a Enzyme Controls (assayed And Unassayed) (Class I - General Controls, product code JJT).
Submitted by Seragen Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 25, 1985, 71 days after receiving the submission on April 15, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K851520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1985 |
| Decision Date | June 25, 1985 |
| Days to Decision | 71 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 |