The following data is part of a premarket notification filed by Bio Clinic Co. with the FDA for Elisa Tube Tsh Test.
| Device ID | K921958 |
| 510k Number | K921958 |
| Device Name: | ELISA TUBE TSH TEST |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BIO CLINIC CO. 5977 SOUTHWEST AVE. St. Louis, MI 63139 |
| Contact | Bruce G Watkins |
| Correspondent | Bruce G Watkins BIO CLINIC CO. 5977 SOUTHWEST AVE. St. Louis, MI 63139 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-27 |
| Decision Date | 1992-07-02 |