The following data is part of a premarket notification filed by Bioclinical Systems, Inc. with the FDA for Micro-elisa Tsh Test Kit-visi-check Tsh Test Kit.
| Device ID | K854379 |
| 510k Number | K854379 |
| Device Name: | MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BIOCLINICAL SYSTEMS, INC. 5977 SOUTHWEST AVE. St.louis, MO 63139 |
| Contact | Bruce F Watkins |
| Correspondent | Bruce F Watkins BIOCLINICAL SYSTEMS, INC. 5977 SOUTHWEST AVE. St.louis, MO 63139 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-30 |
| Decision Date | 1986-01-07 |