RUBEOLA IGG ELISA TEST

Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

GULL LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK904854
510k NumberK904854
Device Name:RUBEOLA IGG ELISA TEST
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubeola Igg
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 CodeLJB  
CFR Regulation Number866.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-10-29
Decision Date1990-12-04

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