ANTISERUM TO HUMAN APOLIPOPROTEIN B

Apolipoproteins

KENT LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK850690
510k NumberK850690
Device Name:ANTISERUM TO HUMAN APOLIPOPROTEIN B
ClassificationApolipoproteins
Applicant KENT LABORATORIES, INC. 23404 N.E. 8TH ST. Redmond,  WA  98053
ContactAllan H Jorgensen
CorrespondentAllan H Jorgensen
KENT LABORATORIES, INC. 23404 N.E. 8TH ST. Redmond,  WA  98053
Product CodeMSJ  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-21
Decision Date1985-11-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B1761520 K850690 000

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