ANTI-NUCLEAR ANTIBODY TEST

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 Anti-nuclear Antibody Test.

Pre-market Notification Details

Device IDK791493
510k NumberK791493
Device Name:ANTI-NUCLEAR ANTIBODY TEST
ClassificationAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant MELOY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDHN  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-08-02
Decision Date1979-09-24

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