GOAT ANTI-HUMAN IMMUNOGLOBULINS-

Kappa, 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 Immunoglobulins-.

Pre-market Notification Details

Device IDK832256
510k NumberK832256
Device Name:GOAT ANTI-HUMAN IMMUNOGLOBULINS-
ClassificationKappa, Antigen, Antiserum, Control
Applicant GELCO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDFH  
CFR Regulation Number866.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-06-30
Decision Date1983-10-31

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