K913742 is an FDA 510(k) clearance for the IL TEST(TM) OPIATE. This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on November 7, 1991, 79 days after receiving the submission on August 20, 1991.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K913742 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1991 |
| Decision Date | November 07, 1991 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |