Cleared Traditional

GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK

K103673 · Techlab Inc., Corporate Research Center · Microbiology

Aug 2011

Decision

245d

Days

Class 2

Risk

About This 510(k) Submission

K103673 is an FDA 510(k) clearance for the GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK, a Giardia Spp. (Class II — Special Controls, product code MHI), submitted by Techlab Inc., Corporate Research Center (Blacksburg, US). The FDA issued a Cleared decision on August 18, 2011, 245 days after receiving the submission on December 16, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number	K103673 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 2010
Decision Date	August 18, 2011
Days to Decision	245 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF