The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Intact Pth, Model Lkpp1 (100 Tests), Lkpp5 (500 Tests), Immulite 2000 Intact Pth, Model L2kpp (200 Tests), L2k6.
| Device ID | K011505 |
| 510k Number | K011505 |
| Device Name: | IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6 |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| 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 | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-16 |
| Decision Date | 2001-07-02 |