IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA

Iga, 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.-iga.

Pre-market Notification Details

• Device ID: K812488
• 510k Number: K812488
• Device Name: IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA
• Classification: Iga, Antigen, Antiserum, Control
• Applicant: DAKO CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: CZP
• CFR Regulation Number: 866.5510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-08-31
• Decision Date: 1981-09-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05700572000617	K812488	000