CMV-EA MAB TEST

Antisera, Conjugated Fluorescent, Cytomegalovirus

GULL LABORATORIES, INC.

The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Cmv-ea Mab Test.

Pre-market Notification Details

Device IDK912592
510k NumberK912592
Device Name:CMV-EA MAB TEST
ClassificationAntisera, Conjugated Fluorescent, Cytomegalovirus
Applicant GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City,  UT  84117
ContactFred W Rachford
CorrespondentFred W Rachford
GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City,  UT  84117
Product CodeLIN  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-10
Decision Date1991-12-04

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