Cleared Traditional

ELISA CMV IGM

K914789 · Sclavo, Inc. · Microbiology
Mar 1992
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K914789 is an FDA 510(k) clearance for the ELISA CMV IGM, a Antibody Igm,if, Cytomegalovirus Virus (Class II — Special Controls, product code LKQ), submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on March 4, 1992, 133 days after receiving the submission on October 23, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K914789 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 1991
Decision Date March 04, 1992
Days to Decision 133 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LKQ — Antibody Igm,if, Cytomegalovirus Virus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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