THE GOLDEN QUAD TEST (HSV)

Antisera, Cf, Herpesvirus Hominis 1,2

MICROBIOLOGICAL RESEARCH CORP.

The following data is part of a premarket notification filed by Microbiological Research Corp. with the FDA for The Golden Quad Test (hsv).

Pre-market Notification Details

Device IDK861120
510k NumberK861120
Device Name:THE GOLDEN QUAD TEST (HSV)
ClassificationAntisera, Cf, Herpesvirus Hominis 1,2
Applicant MICROBIOLOGICAL RESEARCH CORP. P.O. BOX 308 Bountiful,  UT  84010
ContactCarole A Golden
CorrespondentCarole A Golden
MICROBIOLOGICAL RESEARCH CORP. P.O. BOX 308 Bountiful,  UT  84010
Product CodeGQO  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-25
Decision Date1987-02-02

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