The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Dhea-s Reagent Assay.
| Device ID | K040181 |
| 510k Number | K040181 |
| Device Name: | ACCESS DHEA-S REAGENT ASSAY |
| Classification | Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Contact | Mary Beth Tang |
| Correspondent | Mary Beth Tang BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Product Code | JKC |
| CFR Regulation Number | 862.1245 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-27 |
| Decision Date | 2004-03-24 |
| Summary: | summary |