K944731 is an FDA 510(k) clearance for the ABBOTT IMX 2 ANALYZER. This device is classified as a Analyzer, Enzyme, For Clinical Use (Class I - General Controls, product code JJI).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 19, 1994, 98 days after receiving the submission on September 12, 1994.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2500.
| 510(k) Number | K944731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 1994 |
| Decision Date | December 19, 1994 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | JJI — Analyzer, Enzyme, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2500 |