The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite/immulite 1000 Total Testosterone And Immulite 2000 Total Testosterone.
| Device ID | K032881 |
| 510k Number | K032881 |
| Device Name: | IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-15 |
| Decision Date | 2003-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414962221 | K032881 | 000 |
| 00630414962214 | K032881 | 000 |
| 00630414964782 | K032881 | 000 |