K854946 is an FDA 510(k) clearance for the TDXR 5-HIAA (URINE). This device is classified as a Acid, Nitrous And Nitrosonaphthol, 5-hydroxyindole Acetic Acid/serotonin (Class I - General Controls, product code CDA).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 17, 1986, 38 days after receiving the submission on December 10, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1390.
| 510(k) Number | K854946 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 1985 |
| Decision Date | January 17, 1986 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDA — Acid, Nitrous And Nitrosonaphthol, 5-hydroxyindole Acetic Acid/serotonin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1390 |