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510(k) K012115

SERIM BLOOD LEAK TEST STRIP-2 by Serim Research Corp. — Product Code FJD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2001
Date Received
July 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector, Leak, Blood
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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