K914815 is an FDA 510(k) clearance for the IL TEST(TM) BENZODIAZEPINE. This device is classified as a Enzyme Immunoassay, Benzodiazepine (Class II - Special Controls, product code JXM).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on January 27, 1992, 94 days after receiving the submission on October 25, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3170.
| 510(k) Number | K914815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1991 |
| Decision Date | January 27, 1992 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JXM — Enzyme Immunoassay, Benzodiazepine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3170 |