Cleared Traditional

GIARDIA/CRYPTOSPORIDIUM CHEK

K051929 · Techlab, Inc. · Microbiology
Nov 2005
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K051929 is an FDA 510(k) clearance for the GIARDIA/CRYPTOSPORIDIUM CHEK, a Cryptosporidium Spp. (Class II — Special Controls, product code MHJ), submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on November 17, 2005, 127 days after receiving the submission on July 13, 2005. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K051929 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2005
Decision Date November 17, 2005
Days to Decision 127 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MHJ — Cryptosporidium Spp.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3220