Cleared Traditional

VZV BIO-ENZABEAD SCREEN KIT

K833637 · Bionetic Laboratory Products · Immunology
Feb 1984
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K833637 is an FDA 510(k) clearance for the VZV BIO-ENZABEAD SCREEN KIT, a Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (Class II — Special Controls, product code LFY), submitted by Bionetic Laboratory Products (Mchenry, US). The FDA issued a Cleared decision on February 10, 1984, 116 days after receiving the submission on October 17, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number K833637 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 1983
Decision Date February 10, 1984
Days to Decision 116 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code LFY — Enzyme Linked Immunoabsorbent Assay, Varicella-zoster
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3900

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