K861855 is an FDA 510(k) clearance for the HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET. This device is classified as a Dinitrophenyl Hydrazone Measurement (colorimetric), Hydroxybutyric Dehydroge (Class I - General Controls, product code JKF).
Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on June 16, 1986, 33 days after receiving the submission on May 14, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1380.
| 510(k) Number | K861855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 1986 |
| Decision Date | June 16, 1986 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JKF — Dinitrophenyl Hydrazone Measurement (colorimetric), Hydroxybutyric Dehydroge |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1380 |