The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2000 3rd Generation Psa.
| Device ID | K974842 |
| 510k Number | K974842 |
| Device Name: | IMMULITE 2000 3RD GENERATION PSA |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Robert M Di Tullio |
| Correspondent | Robert M Di Tullio DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-24 |
| Decision Date | 1998-04-21 |