K913737 is an FDA 510(k) clearance for the IL TEST(TM) COCAINE. This device is classified as a Enzyme Immunoassay, Cocaine (Class II - Special Controls, product code JXO).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on December 3, 1991, 105 days after receiving the submission on August 20, 1991.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3250.
| 510(k) Number | K913737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1991 |
| Decision Date | December 03, 1991 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | JXO — Enzyme Immunoassay, Cocaine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3250 |