IBD-SCAN

Lactoferrin, Antigen, Antiserum, Control

TECHLAB, INC.

The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Ibd-scan.

Pre-market Notification Details

• Device ID: K042071
• 510k Number: K042071
• Device Name: IBD-SCAN
• Classification: Lactoferrin, Antigen, Antiserum, Control
• Applicant: TECHLAB, INC. 2001 KRAFT DR. Blacksburg, VA 24060 -6358
• Contact: David M Lyerly
• Correspondent: David M Lyerly; TECHLAB, INC. 2001 KRAFT DR. Blacksburg, VA 24060 -6358
• Product Code: DEG
• CFR Regulation Number: 866.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-08-02
• Decision Date: 2004-10-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00857031002288	K042071	000
00857031002097	K042071	000