Submission Details
| 510(k) Number | K873372 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 24, 1987 |
| Decision Date | December 22, 1987 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K873372 is an FDA 510(k) clearance for the HVA & HOMOVANILLIC ACID BY HPLC METHOD, a Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin (Class I — General Controls, product code CDF), submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on December 22, 1987, 120 days after receiving the submission on August 24, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1795.
| 510(k) Number | K873372 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 24, 1987 |
| Decision Date | December 22, 1987 |
| Days to Decision | 120 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 |