IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA

Kappa, Antigen, Antiserum, Control

DAKO CORP.

The following data is part of a premarket notification filed by Dako Corp. with the FDA for Immunogl. Fract. Of Rabbit Antis./kappa.

Pre-market Notification Details

• Device ID: K812661
• 510k Number: K812661
• Device Name: IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA
• Classification: Kappa, Antigen, Antiserum, Control
• Applicant: DAKO CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DFH
• CFR Regulation Number: 866.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-09-18
• Decision Date: 1981-09-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05700572000884	K812661	000