Cleared Special

K033274 - GIARDIA II (FDA 510(k) Clearance)

K033274 · Techlab, Inc. · Microbiology device

Nov 2003

Decision

25d

Days

Class 2

Risk

K033274 is an FDA 510(k) clearance for the GIARDIA II. This device is classified as a Giardia Spp. (Class II - Special Controls, product code MHI).

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on November 4, 2003, 25 days after receiving the submission on October 10, 2003.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number	K033274 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 10, 2003
Decision Date	November 04, 2003
Days to Decision	25 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Statement