K821879 is an FDA 510(k) clearance for the ULTRACHEM T.P.. This device is classified as a Chromatographic Separation, Lactate Dehydrogenase Isoenzymes (Class II - Special Controls, product code CEX).
Submitted by Harleco Diagnostics (Mchenry, US). The FDA issued a Cleared decision on July 14, 1982, 19 days after receiving the submission on June 25, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1445.
| 510(k) Number | K821879 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 1982 |
| Decision Date | July 14, 1982 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEX — Chromatographic Separation, Lactate Dehydrogenase Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1445 |