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510(k) K981207

CLEARPLAN EASY FERTILITY MONITOR by Unipath , Ltd. — Product Code NGE

K981207 is an FDA 510(k) premarket notification submitted by Unipath , Ltd. for the device "CLEARPLAN EASY FERTILITY MONITOR". The FDA issued a decision of Substantially Equivalent on October 28, 1998. The device falls under product code NGE (Test, Luteinizing Hormone (Lh), Over The Counter), 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
October 28, 1998
Date Received
April 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Luteinizing Hormone (Lh), Over The Counter
Device Class
Class I
Regulation Number
862.1485
Review Panel
TX
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)
  • K040329 — MODIFICATION TO E.P.T. PREGNANCY TEST (March 8, 2004)
  • K040341 — CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST (March 8, 2004)
  • K033658 — E.P.T. PREGNANCY TEST (January 16, 2004)
  • K032939 — EPT CERTAINTY PREGNANCY TEST (October 20, 2003)

Other clearances for product code NGE

  • K020808 — FERTILITE OV (September 23, 2002)
  • K990223 — MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR (February 24, 1999)
  • K973860 — OVULON MONITOR (January 7, 1998)
  • K863121 — PEAK OVULATION PREDICTOR (October 14, 1986)
  • K850579 — CUE FERTILITY MONITOR (March 22, 1985)

FDA data resources