ANTISERA TO HUMAN FAB FRAGMENT

Myoglobin, Antigen, Antiserum, Control

KENT LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK771242
510k NumberK771242
Device Name:ANTISERA TO HUMAN FAB FRAGMENT
ClassificationMyoglobin, Antigen, Antiserum, Control
Applicant KENT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDDR  
CFR Regulation Number866.5680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-07-11
Decision Date1977-08-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B176131 K771242 000

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