RABBIT ANTISERUM TO HUMAN IGA

Iga, 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 Iga.

Pre-market Notification Details

• Device ID: K831909
• 510k Number: K831909
• Device Name: RABBIT ANTISERUM TO HUMAN IGA
• Classification: Iga, Fitc, Antigen, Antiserum, Control
• Applicant: DAKO CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: CZN
• CFR Regulation Number: 866.5510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-06-14
• Decision Date: 1983-07-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05700572002543	K831909	000