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510(k) K981271

CLEARPLAN EASY OVULATION TEST by Unipath , Ltd. — Product Code CEP

K981271 is an FDA 510(k) premarket notification submitted by Unipath , Ltd. for the device "CLEARPLAN EASY OVULATION TEST". The FDA issued a decision of Substantially Equivalent on Jun 25, 1998. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Unipath , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 25, 1998
Date Received
Apr 7, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Luteinizing Hormone
Device Class
Class I
Regulation Number
862.1485
Review Panel
CH
Submission Type

Other clearances by Unipath , Ltd.

  • K061769 — E.P.T. CERTAINTY 1-STEP PREGNANCY TEST (Jul 3, 2006)
  • K060128 — CLEARBLUE EASY DIGITAL PREGNANCY TEST (May 25, 2006)
  • K051638 — INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC (Dec 6, 2005)
  • K050930 — E.P.T. CERTAINTY PREGNANCY TEST (May 12, 2005)
  • K042280 — FACT PLUS ONE-STEP PREGNANCY TEST KIT (Sep 10, 2004)
  • K041404 — CLEARBLUE EASY EASY READ PREGNANCY TEST (Jun 8, 2004)
  • K040329 — MODIFICATION TO E.P.T. PREGNANCY TEST (Mar 8, 2004)
  • K040341 — CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST (Mar 8, 2004)
  • K033658 — E.P.T. PREGNANCY TEST (Jan 16, 2004)
  • K032939 — EPT CERTAINTY PREGNANCY TEST (Oct 20, 2003)

Other clearances for product code CEP

  • K013582 — MAYBE?MOM MINI OVULATION MICROSCOPE (Jan 16, 2003)
  • K022829 — INSTANT-VIEW LH OVULATION PREDICTING TEST (Nov 5, 2002)
  • K021409 — AT HOME OVULATION TEST, MODEL 9032 (May 24, 2002)
  • K013874 — CLEARPLANE EASY OVULATION TEST (Feb 19, 2002)
  • K013323 — TCI-31 LIFELONG OVULATION TESTER (Dec 5, 2001)
  • K012252 — QUIK-CHECK OVULATION PREDICTOR (Aug 24, 2001)
  • K010244 — SURE CHECK OVULATION PREDICTOR (May 2, 2001)
  • K002867 — INVERNESS MEDICAL OVULATION PREDICTOR TEST (Oct 12, 2000)
  • K991466 — EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), O (May 25, 1999)
  • K991386 — EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATI (May 25, 1999)

FDA data resources