RUBEOLA TEST

Antiserum, Fluorescent, Rubeola

GULL LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK884004
510k NumberK884004
Device Name:RUBEOLA TEST
ClassificationAntiserum, Fluorescent, Rubeola
Applicant GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City,  UT  84117
ContactRachford, Phd
CorrespondentRachford, Phd
GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City,  UT  84117
Product CodeGRE  
CFR Regulation Number866.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-21
Decision Date1988-12-05

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