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510(k) K092353

MONOLISA ANTI-HAV IGM EIA by Bio-Rad Laboratories, Inc. — Product Code LOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2009
Date Received
August 4, 2009
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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