K813523 is an FDA 510(k) clearance for the ELECTRIC SELF STERILIZATION INOCUL. LOOP. This device is classified as a Cyclosporine Radioimmunoassay (Class II - Special Controls, product code LTB).
Submitted by Techhnilab Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on December 31, 1981, 15 days after receiving the submission on December 16, 1981.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1235.
| 510(k) Number | K813523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 1981 |
| Decision Date | December 31, 1981 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LTB — Cyclosporine Radioimmunoassay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1235 |