K930010 is an FDA 510(k) clearance for the ACCESS THYROID UPTAKE ASSAY. This device is classified as a Radioimmunoassay, Thyroxine-binding Globulin (Class II - Special Controls, product code CEE).
Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on June 7, 1993, 154 days after receiving the submission on January 4, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1685.
| 510(k) Number | K930010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 1993 |
| Decision Date | June 07, 1993 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CEE — Radioimmunoassay, Thyroxine-binding Globulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1685 |