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 |