K023048 is an FDA 510(k) clearance for the MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT. This device is classified as a Enzyme Immunoassay, Benzodiazepine (Class II - Special Controls, product code JXM).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on November 7, 2002, 55 days after receiving the submission on September 13, 2002.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3170.
| 510(k) Number | K023048 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2002 |
| Decision Date | November 07, 2002 |
| Days to Decision | 55 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | JXM — Enzyme Immunoassay, Benzodiazepine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3170 |