IMMULITE EPO, MODEL #'S LKEPZ & LKEP1

Assay, Erythropoietin

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Epo, Model #'s Lkepz & Lkep1.

Pre-market Notification Details

Device IDK983203
510k NumberK983203
Device Name:IMMULITE EPO, MODEL #'S LKEPZ & LKEP1
ClassificationAssay, Erythropoietin
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 CodeGGT  
CFR Regulation Number864.7250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-14
Decision Date1999-07-12
Summary:summary

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