K772151 is an FDA 510(k) clearance for the URINARY VMA - SCREEN TEST KIT. This device is classified as a Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin (Class I - General Controls, product code CDF).
Submitted by Eppendorf-Brinkmann, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 30, 1977, 15 days after receiving the submission on November 15, 1977.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1795.
| 510(k) Number | K772151 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 1977 |
| Decision Date | November 30, 1977 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDF — Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1795 |