Cleared Traditional

VZV IGG ELISA TEST

K941046 · Gull Laboratories, Inc. · Microbiology
Aug 1995
Decision
535d
Days
Class 2
Risk

About This 510(k) Submission

K941046 is an FDA 510(k) clearance for the VZV IGG ELISA TEST, a Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (Class II — Special Controls, product code LFY), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 24, 1995, 535 days after receiving the submission on March 7, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number K941046 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1994
Decision Date August 24, 1995
Days to Decision 535 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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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