K934384 is an FDA 510(k) clearance for the AXSYM(TM) TOTAL T4. This device is classified as a Radioimmunoassay, Total Thyroxine (Class II - Special Controls, product code CDX).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 21, 1994, 293 days after receiving the submission on September 1, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1700.
| 510(k) Number | K934384 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1993 |
| Decision Date | June 21, 1994 |
| Days to Decision | 293 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CDX — Radioimmunoassay, Total Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1700 |