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510(k) K161964

ADVIA Centaur HAV IgM Assay by Siemens Healthcare Diagnostics, Inc. — Product Code LOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2016
Date Received
July 18, 2016
Clearance Type
Traditional
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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  • K193532 — LIAISON Anti-HAV Assay (March 2, 2020)
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  • K142758 — ADVIA Centaur HAV total assay (December 5, 2014)
  • K141116 — LIAISON XL ANALYZER (July 25, 2014)