GIARDIA/CRYPTOSPORIDIUM CHEK

Cryptosporidium Spp.

TECHLAB, INC.

The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Giardia/cryptosporidium Chek.

Pre-market Notification Details

• Device ID: K051929
• 510k Number: K051929
• Device Name: GIARDIA/CRYPTOSPORIDIUM CHEK
• Classification: Cryptosporidium Spp.
• Applicant: TECHLAB, INC. 2001 KRAFT DR. Blacksburg, VA 24060 -6358
• Contact: David M Lyrly
• Correspondent: David M Lyrly; TECHLAB, INC. 2001 KRAFT DR. Blacksburg, VA 24060 -6358
• Product Code: MHJ
• CFR Regulation Number: 866.3220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-07-13
• Decision Date: 2005-11-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00857031002240	K051929	000
00857031002127	K051929	000