ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A

Antigens, Cf (including Cf Control), Influenza Virus A, B, C

MICROSCAN DIV. BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Microscan Div. Baxter Healthcare Corp. with the FDA for Antibody Assay For Detection Of Influenza A.

Pre-market Notification Details

Device IDK871233
510k NumberK871233
Device Name:ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A
ClassificationAntigens, Cf (including Cf Control), Influenza Virus A, B, C
Applicant MICROSCAN DIV. BAXTER HEALTHCARE CORP. 2040 ENTERPRISE BLVD. W. Sacramento,  CA  95691
ContactHoward G Taylor
CorrespondentHoward G Taylor
MICROSCAN DIV. BAXTER HEALTHCARE CORP. 2040 ENTERPRISE BLVD. W. Sacramento,  CA  95691
Product CodeGNX  
CFR Regulation Number866.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-27
Decision Date1987-06-26

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