K870968 is an FDA 510(k) clearance for the TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT. This device is classified as a Radioimmunoassay, Total Triiodothyronine (Class II - Special Controls, product code CDP).
Submitted by Canadian Bioclinical, Ltd. (Ontario Mix 1b4, CA). The FDA issued a Cleared decision on June 22, 1987, 104 days after receiving the submission on March 10, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1710.
| 510(k) Number | K870968 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1987 |
| Decision Date | June 22, 1987 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDP — Radioimmunoassay, Total Triiodothyronine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1710 |