The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin Calibrators And Access Sex Hormone Bind.
| Device ID | K083867 |
| 510k Number | K083867 |
| Device Name: | ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Tyler Foutch |
| Correspondent | Tyler Foutch BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | CDZ |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-29 |
| Decision Date | 2009-08-27 |
| Summary: | summary |