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510(k) K061769

E.P.T. CERTAINTY 1-STEP PREGNANCY TEST by Unipath , Ltd. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2006
Date Received
June 23, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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  • K033658 — E.P.T. PREGNANCY TEST (January 16, 2004)
  • K032939 — EPT CERTAINTY PREGNANCY TEST (October 20, 2003)
  • K030659 — CLEARBLUE EASY DIGITAL PREGNANCY TEST (May 2, 2003)

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