IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6

Radioimmunoassay, Parathyroid Hormone

DIAGNOSTIC PRODUCTS CORP.

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.

Pre-market Notification Details

Device IDK013566
510k NumberK013566
Device Name:IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
ClassificationRadioimmunoassay, Parathyroid Hormone
Applicant DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
ContactEdward M Levine
CorrespondentEdward M Levine
DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
Product CodeCEW  
CFR Regulation Number862.1545 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-26
Decision Date2001-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414964515 K013566 000
00630414961927 K013566 000
00630414961910 K013566 000
00630414954059 K013566 000
00630414954042 K013566 000
00630414953236 K013566 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.