The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Dhea-s04.
| Device ID | K935806 |
| 510k Number | K935806 |
| Device Name: | IMMULITE DHEA-S04 |
| Classification | Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Deborah Wilmers |
| Correspondent | Deborah Wilmers DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | JKC |
| CFR Regulation Number | 862.1245 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-02 |
| Decision Date | 1994-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414963884 | K935806 | 000 |
| 00630414961309 | K935806 | 000 |
| 00630414953694 | K935806 | 000 |
| 00630414167428 | K935806 | 000 |