Cleared Traditional

E. HISTOLYTICA TEST

K955895 · Techlab, Inc. · Microbiology
Aug 1996
Decision
248d
Days
Class 2
Risk

About This 510(k) Submission

K955895 is an FDA 510(k) clearance for the E. HISTOLYTICA 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 August 30, 1996, 248 days after receiving the submission on December 26, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K955895 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 1995
Decision Date August 30, 1996
Days to Decision 248 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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