HUMAN IGG-ALBUMIN TEST KIT

Radial Immunodiffusion, Albumin

MELOY LABORATORIES, INC.

The following data is part of a premarket notification filed by Meloy Laboratories, Inc. with the FDA for Human Igg-albumin Test Kit.

Pre-market Notification Details

Device IDK811178
510k NumberK811178
Device Name:HUMAN IGG-ALBUMIN TEST KIT
ClassificationRadial Immunodiffusion, Albumin
Applicant MELOY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCJQ  
CFR Regulation Number862.1035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-04-28
Decision Date1981-05-15

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