Home / 510(k) Clearances / K093955

510(k) K093955

ANTI-HAV IGM by Roche Diagnostics — Product Code LOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2010
Date Received
December 23, 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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