The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Psa Control Module, Model Lpscm.
| Device ID | K982637 |
| 510k Number | K982637 |
| Device Name: | IMMULITE PSA CONTROL MODULE, MODEL LPSCM |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-29 |
| Decision Date | 1998-08-12 |
| Summary: | summary |