IMMULITE TURBO INTACT PTH, MODEL LSKPTZ

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 Turbo Intact Pth, Model Lskptz.

Pre-market Notification Details

Device IDK992105
510k NumberK992105
Device Name:IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
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 Received1999-06-22
Decision Date1999-07-06
Summary:summary

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