Cleared Traditional

AMEBIASIS BIO-ENZABEAD SCREEN KIT

K831133 · Bionetic Laboratory Products · Immunology
Jun 1983
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K831133 is an FDA 510(k) clearance for the AMEBIASIS BIO-ENZABEAD SCREEN KIT, a Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. (Class II — Special Controls, product code KHW), submitted by Bionetic Laboratory Products (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983, 62 days after receiving the submission on April 7, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K831133 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1983
Decision Date June 08, 1983
Days to Decision 62 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

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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