Cleared Traditional

IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,

K100433 · Siemens Healthcare Diagnostics · Microbiology
May 2010
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K100433 is an FDA 510(k) clearance for the IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,, a Antibody Igm,if, Cytomegalovirus Virus (Class II — Special Controls, product code LKQ), submitted by Siemens Healthcare Diagnostics (West Sacramento, US). The FDA issued a Cleared decision on May 13, 2010, 86 days after receiving the submission on February 16, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K100433 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2010
Decision Date May 13, 2010
Days to Decision 86 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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