K952284 is an FDA 510(k) clearance for the AMERLITE TBG ASSAY. This device is classified as a Radioimmunoassay, Thyroxine-binding Globulin (Class II - Special Controls, product code CEE).
Submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on July 26, 1995, 71 days after receiving the submission on May 16, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1685.
| 510(k) Number | K952284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 1995 |
| Decision Date | July 26, 1995 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CEE — Radioimmunoassay, Thyroxine-binding Globulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1685 |