Cleared Special

E. HISTOLYTICA II

K994101 · Techlab, Inc. · Microbiology
Dec 1999
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K994101 is an FDA 510(k) clearance for the E. HISTOLYTICA II, 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 December 21, 1999, 15 days after receiving the submission on December 6, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K994101 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 1999
Decision Date December 21, 1999
Days to Decision 15 days
Submission Type Special
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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