K890689 is an FDA 510(k) clearance for the ADX TM OPIATES. This device is classified as a Colostrum, Antigen, Antiserum, Control (Class I - General Controls, product code DGJ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 25, 1989, 192 days after receiving the submission on February 14, 1989.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 866.5230.
| 510(k) Number | K890689 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 1989 |
| Decision Date | August 25, 1989 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DGJ — Colostrum, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5230 |