FITC ANTISERA TO HUMAN GOBULIN

Kappa, Antigen, Antiserum, Control

AMICO LAB, INC.

The following data is part of a premarket notification filed by Amico Lab, Inc. with the FDA for Fitc Antisera To Human Gobulin.

Pre-market Notification Details

Device IDK822678
510k NumberK822678
Device Name:FITC ANTISERA TO HUMAN GOBULIN
ClassificationKappa, Antigen, Antiserum, Control
Applicant AMICO LAB, 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 Received1982-09-03
Decision Date1982-11-17

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