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510(k) K033658

E.P.T. PREGNANCY TEST by Unipath , Ltd. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2004
Date Received
November 21, 2003
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

Other clearances by Unipath , Ltd.

  • K061769 — E.P.T. CERTAINTY 1-STEP PREGNANCY TEST (July 3, 2006)
  • K060128 — CLEARBLUE EASY DIGITAL PREGNANCY TEST (May 25, 2006)
  • K051638 — INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC (December 6, 2005)
  • K050930 — E.P.T. CERTAINTY PREGNANCY TEST (May 12, 2005)
  • K042280 — FACT PLUS ONE-STEP PREGNANCY TEST KIT (September 10, 2004)
  • K041404 — CLEARBLUE EASY EASY READ PREGNANCY TEST (June 8, 2004)
  • K040341 — CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST (March 8, 2004)
  • K040329 — MODIFICATION TO E.P.T. PREGNANCY TEST (March 8, 2004)
  • K032939 — EPT CERTAINTY PREGNANCY TEST (October 20, 2003)
  • K030659 — CLEARBLUE EASY DIGITAL PREGNANCY TEST (May 2, 2003)

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  • K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (December 20, 2024)
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  • K241978 — Shinetell Digital Pregnancy Test (August 13, 2024)
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