K871549 is an FDA 510(k) clearance for the RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]. This device is classified as a Radioimmunoassay, Cocaine Metabolite (Class II - Special Controls, product code KLN).
Submitted by Immunalysis Corporation (Glendale, US). The FDA issued a Cleared decision on June 16, 1987, 63 days after receiving the submission on April 14, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3250.
| 510(k) Number | K871549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1987 |
| Decision Date | June 16, 1987 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KLN — Radioimmunoassay, Cocaine Metabolite |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3250 |