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510(k) K072500

ONE STEP HCG URINE/SERUM TEST by Guangzhou Wondfo Biotech Co., Ltd. — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2009
Date Received
September 5, 2007
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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