ANTISERUM TO HUMAN IGM

Igm (mu Chain Specific), Antigen, Antiserum, Control

KENT LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK790705
510k NumberK790705
Device Name:ANTISERUM TO HUMAN IGM
ClassificationIgm (mu Chain Specific), Antigen, Antiserum, Control
Applicant KENT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDAO  
CFR Regulation Number866.5550 [🔎]
DecisionSe - Postmarket Surveillance Required (SESP)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-04-12
Decision Date1979-04-12

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