ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT

Immunoassay Method, Troponin Subunit

FIRST MEDICAL, INC.

The following data is part of a premarket notification filed by First Medical, Inc. with the FDA for Alpha Dx Analyzer 01-0100, Alpha Dx Myo/ck/ck-mb/tni Cardiac Panel Test Kit 03-0001, Alpha Dx Ck/ck-mb Panel Test Kit.

Pre-market Notification Details

Device IDK974839
510k NumberK974839
Device Name:ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT
ClassificationImmunoassay Method, Troponin Subunit
Applicant FIRST MEDICAL, INC. 530 LOGUE AVE. Mountain View,  CA  94043
ContactVan N Johnson
CorrespondentVan N Johnson
FIRST MEDICAL, INC. 530 LOGUE AVE. Mountain View,  CA  94043
Product CodeMMI  
Subsequent Product CodeCGX
Subsequent Product CodeDDR
Subsequent Product CodeJHX
Subsequent Product CodeKHO
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-24
Decision Date1998-02-04
Summary:summary

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