Cleared Traditional

ENTAMOEBA TEST

K944791 · Techlab, Inc. · Microbiology
Mar 1995
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K944791 is an FDA 510(k) clearance for the ENTAMOEBA TEST, a Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. (Class II — Special Controls, product code KHW), submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on March 9, 1995, 162 days after receiving the submission on September 28, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K944791 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 1994
Decision Date March 09, 1995
Days to Decision 162 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code KHW — Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3220

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