The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Intact Pth, Immulite 2000 Intact Pth, Models Lkpp1 (100 Tests), Lkpp5 (500 Tests), L2kpp2 (200 Tests), L2kpp6.
| Device ID | K013566 |
| 510k Number | K013566 |
| Device Name: | IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-26 |
| Decision Date | 2001-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414964515 | K013566 | 000 |
| 00630414961927 | K013566 | 000 |
| 00630414961910 | K013566 | 000 |
| 00630414954059 | K013566 | 000 |
| 00630414954042 | K013566 | 000 |
| 00630414953236 | K013566 | 000 |