GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC

Iga, Fitc, Antigen, Antiserum, Control

GELCO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Gelco Diagnostics, Inc. with the FDA for Goat Anti-human Iga A Chain Specific.

Pre-market Notification Details

Device IDK832257
510k NumberK832257
Device Name:GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC
ClassificationIga, Fitc, Antigen, Antiserum, Control
Applicant GELCO DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCZN  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-06-30
Decision Date1983-10-28

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