The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access Estradiol Reagents On The Access Immunoassay Analyzer (33550,33540,33545).
| Device ID | K970126 |
| 510k Number | K970126 |
| Device Name: | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) |
| Classification | Radioimmunoassay, Estradiol |
| Applicant | BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Sandra F Schwartz, Ph.d. |
| Correspondent | Sandra F Schwartz, Ph.d. BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-14 |
| Decision Date | 1997-02-25 |
| Summary: | summary |