Cleared Abbreviated

VIROCULT, MODEL MW950

K082472 · Medical Wire & Equipment Company (Bath), Ltd. · Microbiology
Dec 2008
Decision
124d
Days
Class 1
Risk

About This 510(k) Submission

K082472 is an FDA 510(k) clearance for the VIROCULT, MODEL MW950, a Device, Specimen Collection (Class I — General Controls, product code LIO), submitted by Medical Wire & Equipment Company (Bath), Ltd. (Corsham, Wiltshire, GB). The FDA issued a Cleared decision on December 30, 2008, 124 days after receiving the submission on August 28, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K082472 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2008
Decision Date December 30, 2008
Days to Decision 124 days
Submission Type Abbreviated
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIO — Device, Specimen Collection
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2900

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