The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2000 Psa.
| Device ID | K972095 |
| 510k Number | K972095 |
| Device Name: | IMMULITE 2000 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 Ditullio |
| Correspondent | Robert M Ditullio 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 | 1997-06-04 |
| Decision Date | 1997-08-22 |