LEECO-SCREEN, STREP A (EIA)

Antisera, All Groups, Streptococcus Spp.

LEECO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco-screen, Strep A (eia).

Pre-market Notification Details

Device IDK860947
510k NumberK860947
Device Name:LEECO-SCREEN, STREP A (EIA)
ClassificationAntisera, All Groups, Streptococcus Spp.
Applicant LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
ContactLee, Ph.d.
CorrespondentLee, Ph.d.
LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
Product CodeGTZ  
CFR Regulation Number866.3740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-12
Decision Date1986-05-13

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