K952817 is an FDA 510(k) clearance for the BIO-RAD URINARY 5-HIAA BY HPLC. This device is classified as a Acid, Nitrous And Nitrosonaphthol, 5-hydroxyindole Acetic Acid/serotonin (Class I - General Controls, product code CDA).
Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on August 1, 1995, 42 days after receiving the submission on June 20, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1390.
| 510(k) Number | K952817 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 1995 |
| Decision Date | August 01, 1995 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CDA — Acid, Nitrous And Nitrosonaphthol, 5-hydroxyindole Acetic Acid/serotonin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1390 |