ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1

Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4

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 Detect. Of Parainfluenza Type 1.

Pre-market Notification Details

Device IDK871234
510k NumberK871234
Device Name:ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1
ClassificationAntigens, Cf (including Cf Control), Parainfluenza Virus 1-4
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 CodeGQS  
CFR Regulation Number866.3400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-27
Decision Date1987-06-26

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