The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access Hypersensitive Tsh Reagents On The Access Immunoassay Analyzer.
| Device ID | K954825 |
| 510k Number | K954825 |
| Device Name: | ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Jan Olsen |
| Correspondent | Jan Olsen BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-20 |
| Decision Date | 1995-11-21 |