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510(k) K851891

TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS by Richard Scott Elliott — Product Code LOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1985
Date Received
April 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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