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510(k) K100433

IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, by Siemens Healthcare Diagnostics — Product Code LKQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 13, 2010
Date Received: February 16, 2010
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Antibody Igm,If, Cytomegalovirus Virus
Device Class: Class II
Regulation Number: 866.3175
Review Panel: MI
Submission Type

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Other clearances for product code LKQ

K972884 — ACCURUN 146 CMV IGM POSITIVE CONTROL (August 22, 1997)
K933549 — VIDAS CMV IGM ASSAY (August 2, 1994)
K922580 — BARTELS CYTOMEGALOVIRUS IGM EIA (April 8, 1993)
K914789 — ELISA CMV IGM (March 4, 1992)
K913080 — OPUS(R) ANTI CMV-M (October 28, 1991)
K900743 — CMV-IGM IFA TEST SYSTEM (April 26, 1990)
K893465 — CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) (July 25, 1989)
K893466 — CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) (July 14, 1989)
K872881 — ABBOTT CMV-M EIA KIT (May 13, 1988)
K872942 — IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 (January 11, 1988)