K941427 is an FDA 510(k) clearance for the SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH). This device is classified as a Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase (Class I - General Controls, product code JMK).
Submitted by Teco Diagnostics (Placentia, US). The FDA issued a Cleared decision on March 13, 1995, 354 days after receiving the submission on March 24, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1380.
| 510(k) Number | K941427 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1994 |
| Decision Date | March 13, 1995 |
| Days to Decision | 354 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JMK — Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1380 |