ANTI SERA TO HUMAN OROSCOMUCOID

Alpha-1-b-glycoprotein, Antigen, Antiserum, Control

KENT LABORATORIES, INC.

The following data is part of a premarket notification filed by Kent Laboratories, Inc. with the FDA for Anti Sera To Human Oroscomucoid.

Pre-market Notification Details

Device IDK823765
510k NumberK823765
Device Name:ANTI SERA TO HUMAN OROSCOMUCOID
ClassificationAlpha-1-b-glycoprotein, Antigen, Antiserum, Control
Applicant KENT LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDEX  
CFR Regulation Number866.5420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-14
Decision Date1982-12-30

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