IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I

Fluorometric Method, Cpk Or Isoenzymes

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2500 Ck-mb, 2500 Myoglobin, 2500 Stat Troponin I.

Pre-market Notification Details

Device IDK034055
510k NumberK034055
Device Name:IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
ClassificationFluorometric Method, Cpk Or Isoenzymes
Applicant DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
ContactEdward M Levine, Ph.d.
CorrespondentEdward M Levine, Ph.d.
DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
Product CodeJHX  
Subsequent Product CodeDDR
Subsequent Product CodeMMI
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-30
Decision Date2004-01-21
Summary:summary

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