LUPUS(LE)-LATEX TEST

Antisera, Fluorescent, Chlamydia Spp.

IMMCO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Lupus(le)-latex Test.

Pre-market Notification Details

Device IDK905531
510k NumberK905531
Device Name:LUPUS(LE)-LATEX TEST
ClassificationAntisera, Fluorescent, Chlamydia Spp.
Applicant IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo,  NY  14223
ContactSusan Krasny
CorrespondentSusan Krasny
IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo,  NY  14223
Product CodeLKI  
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-10
Decision Date1991-01-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.