K863877 is an FDA 510(k) clearance for the BENZODIAZEPINE ENZYME IMMUNOASSAY KIT. This device is classified as a Enzyme Immunoassay, Benzodiazepine (Class II - Special Controls, product code JXM).
Submitted by General Diagnostics (Great Neck, US). The FDA issued a Cleared decision on March 12, 1987, 157 days after receiving the submission on October 6, 1986.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3170.
| 510(k) Number | K863877 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 1986 |
| Decision Date | March 12, 1987 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | JXM — Enzyme Immunoassay, Benzodiazepine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3170 |