K892650 is an FDA 510(k) clearance for the TDX BARBITURATES SERUM. This device is classified as a Enzyme Immunoassay, Barbiturate (Class II - Special Controls, product code DIS).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 16, 1989, 34 days after receiving the submission on April 12, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3150.
| 510(k) Number | K892650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 1989 |
| Decision Date | May 16, 1989 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DIS — Enzyme Immunoassay, Barbiturate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3150 |