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510(k) K080094

OLYMPUS TOTAL BHCG TEST SYSTEN by Olympus Life Science Research Europa GmbH (Europa) — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2008
Date Received
January 14, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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