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510(k) K981207

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

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

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Other clearances for product code NGE

  • K020808 — FERTILITE OV (September 23, 2002)
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  • K973860 — OVULON MONITOR (January 7, 1998)
  • K863121 — PEAK OVULATION PREDICTOR (October 14, 1986)
  • K850579 — CUE FERTILITY MONITOR (March 22, 1985)