The following data is part of a premarket notification filed by Cis-us, Inc. with the FDA for Tshk-nn Ria Kit.
| Device ID | K860824 |
| 510k Number | K860824 |
| Device Name: | TSHK-NN RIA KIT |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | CIS-US, INC. 1983 MARCUS AVE. Lake Success, NY 11042 |
| Contact | Michael D Garrett |
| Correspondent | Michael D Garrett CIS-US, INC. 1983 MARCUS AVE. Lake Success, NY 11042 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-04-28 |