IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG

Igg, Antigen, Antiserum, Control

DAKO CORP.

The following data is part of a premarket notification filed by Dako Corp. with the FDA for Immunogl. Frct. Of Rabbit Antiser.-igg.

Pre-market Notification Details

Device IDK812489
510k NumberK812489
Device Name:IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG
ClassificationIgg, Antigen, Antiserum, Control
Applicant DAKO CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDEW  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-08-31
Decision Date1981-09-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05700572001386 K812489 000

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