The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Total Testosterone.
| Device ID | K955870 |
| 510k Number | K955870 |
| Device Name: | IMMULITE TOTAL TESTOSTERONE |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Edward M Levine |
| Correspondent | Edward M Levine DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-28 |
| Decision Date | 1996-02-06 |