Cleared Traditional

CMV IGG ELISA TEST

K915892 · Gull Laboratories, Inc. · Microbiology
Feb 1992
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K915892 is an FDA 510(k) clearance for the CMV IGG ELISA TEST, a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II — Special Controls, product code LFZ), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 14, 1992, 52 days after receiving the submission on December 24, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K915892 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 1991
Decision Date February 14, 1992
Days to Decision 52 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFZ — Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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