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510(k) K081716

ADVIA CENTAUR HAVM ASSAY by Siemens Healthcare Diagnostics, Inc. — Product Code LOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2008
Date Received
June 18, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hepatitis A Test (Antibody And Igm Antibody)
Device Class
Class II
Regulation Number
866.3310
Review Panel
MI
Submission Type

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Other clearances for product code LOL

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