ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI

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-native Deoxyrib-onucleic Acid Anti.

Pre-market Notification Details

Device IDK790252
510k NumberK790252
Device Name:ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI
ClassificationAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant MELOY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDHN  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-02-06
Decision Date1979-03-15

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