K991079 is an FDA 510(k) clearance for the ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO. This device is classified as a Enzyme Immunoassay, Benzodiazepine (Class II - Special Controls, product code JXM).
Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on April 15, 1999, 20 days after receiving the submission on March 26, 1999.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3170.
| 510(k) Number | K991079 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1999 |
| Decision Date | April 15, 1999 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | JXM — Enzyme Immunoassay, Benzodiazepine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3170 |