IBD-CHEK

Lactoferrin, Antigen, Antiserum, Control

TECHLAB, INC.

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

Pre-market Notification Details

• Device ID: K011396
• 510k Number: K011396
• Device Name: IBD-CHEK
• Classification: Lactoferrin, Antigen, Antiserum, Control
• Applicant: TECHLAB, INC. 1861 PRATT DR., STE. 1030 Blacksburg, VA 24060 -6364
• Contact: David M Lyerly
• Correspondent: David M Lyerly; TECHLAB, INC. 1861 PRATT DR., STE. 1030 Blacksburg, VA 24060 -6364
• Product Code: DEG
• CFR Regulation Number: 866.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-05-07
• Decision Date: 2001-06-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00857031002271	K011396	000
00857031002080	K011396	000