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510(k) K990206

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1999
Date Received
January 21, 1999
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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