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FDA 510(k) Application Details - K100433
Device Classification Name
Antibody Igm,If, Cytomegalovirus Virus
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510(K) Number
K100433
Device Name
Antibody Igm,If, Cytomegalovirus Virus
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
1584 ENTERPRISE BLVD
WEST SACRAMENTO, CA 95691 US
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Contact
ROBERT C EUSEBIO
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Regulation Number
866.3175
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Classification Product Code
LKQ
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More FDA Info for this Product Code
Date Received
02/16/2010
Decision Date
05/13/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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