SS-A(RO) & SS-B(LA) ANTIBODY ASSAY

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

MELOY LABORATORIES, INC.

The following data is part of a premarket notification filed by Meloy Laboratories, Inc. with the FDA for Ss-a(ro) & Ss-b(la) Antibody Assay.

Pre-market Notification Details

Device IDK852033
510k NumberK852033
Device Name:SS-A(RO) & SS-B(LA) ANTIBODY ASSAY
ClassificationAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant MELOY LABORATORIES, INC. 6715 ELECTRONIC DR. Springfield,  VA  22151
ContactRobert H Fennell
CorrespondentRobert H Fennell
MELOY LABORATORIES, INC. 6715 ELECTRONIC DR. Springfield,  VA  22151
Product CodeDHN  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-09
Decision Date1985-06-21

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