The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Access Estradiol Reagents On The Access Immunoassay Analyzer.
| Device ID | K973743 |
| 510k Number | K973743 |
| Device Name: | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
| Classification | Radioimmunoassay, Estradiol |
| Applicant | BECKMAN INSTRUMENTS, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Michele Z Burtness |
| Correspondent | Michele Z Burtness BECKMAN INSTRUMENTS, 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 | 1997-10-01 |
| Decision Date | 1997-10-31 |
| Summary: | summary |