C. DIFF QUIK CHEK

Antigen, C. Difficile

TECHLAB, INC.

The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for C. Diff Quik Chek.

Pre-market Notification Details

• Device ID: K053572
• 510k Number: K053572
• Device Name: C. DIFF QUIK CHEK
• Classification: Antigen, C. Difficile
• 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: MCB
• CFR Regulation Number: 866.2660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-12-22
• Decision Date: 2006-04-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00857031002141	K053572	000