K851514 is an FDA 510(k) clearance for the ULTRA-VIOLET GLUCOSE REAGENT. This device is classified as a Electrode, Ion Specific, Magnesium (Class I - General Controls, product code CFA).
Submitted by Bio-Analytics Laboratories, Inc. (Palm City, US). The FDA issued a Cleared decision on May 20, 1985, 35 days after receiving the submission on April 15, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1495.
| 510(k) Number | K851514 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1985 |
| Decision Date | May 20, 1985 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CFA — Electrode, Ion Specific, Magnesium |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1495 |