FLUORESCEIN CONJUGATED IMMUNOGLOBULIN

Lambda, Fitc, Antigen, Antiserum, Control

DAKO CORP.

The following data is part of a premarket notification filed by Dako Corp. with the FDA for Fluorescein Conjugated Immunoglobulin.

Pre-market Notification Details

• Device ID: K831903
• 510k Number: K831903
• Device Name: FLUORESCEIN CONJUGATED IMMUNOGLOBULIN
• Classification: Lambda, Fitc, Antigen, Antiserum, Control
• Applicant: DAKO CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DES
• CFR Regulation Number: 866.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-06-14
• Decision Date: 1983-07-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05700572002451	K831903	000