CHAGAS' IGG ELISA TEST

Enzyme Linked Immunosorbent Assay, T. Cruzi

GULL LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK911233
510k NumberK911233
Device Name:CHAGAS' IGG ELISA TEST
ClassificationEnzyme Linked Immunosorbent Assay, T. Cruzi
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 CodeMIU  
CFR Regulation Number866.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-20
Decision Date1992-05-04

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