VZV IGG ELISA TEST

Enzyme Linked Immunoabsorbent Assay, Varicella-zoster

GULL LABORATORIES, INC.

The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Vzv Igg Elisa Test.

Pre-market Notification Details

Device IDK941046
510k NumberK941046
Device Name:VZV IGG ELISA TEST
ClassificationEnzyme Linked Immunoabsorbent Assay, Varicella-zoster
Applicant GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City,  UT  84117
ContactFred W Rachford, Ph.d
CorrespondentFred W Rachford, Ph.d
GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City,  UT  84117
Product CodeLFY  
CFR Regulation Number866.3900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-07
Decision Date1995-08-24

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