RABBIT ANTISERUM TO HUMAN IGM

Igm, Fitc, Antigen, Antiserum, Control

DAKO CORP.

The following data is part of a premarket notification filed by Dako Corp. with the FDA for Rabbit Antiserum To Human Igm.

Pre-market Notification Details

Device IDK831907
510k NumberK831907
Device Name:RABBIT ANTISERUM TO HUMAN IGM
ClassificationIgm, Fitc, Antigen, Antiserum, Control
Applicant DAKO CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDFS  
CFR Regulation Number866.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-06-14
Decision Date1983-07-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05700572002529 K831907 000

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