The following data is part of a premarket notification filed by Techhnilab Instruments, Inc. with the FDA for Electric Self Sterilization Inocul. Loop.
| Device ID | K813523 |
| 510k Number | K813523 |
| Device Name: | ELECTRIC SELF STERILIZATION INOCUL. LOOP |
| Classification | Cyclosporine Radioimmunoassay |
| Applicant | TECHHNILAB INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LTB |
| CFR Regulation Number | 862.1235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-16 |
| Decision Date | 1981-12-31 |