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510(k) K973860

OVULON MONITOR by Conception Technology, Inc. — Product Code NGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1998
Date Received
October 9, 1997
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 Conception Technology, Inc.

  • K030117 — ENHANCE SPERM FREEZE (March 20, 2003)
  • K030116 — ENHANCE-S PLUS H (February 12, 2003)
  • K991322 — ENHANCE-S PLUS (July 26, 1999)
  • K991104 — MICROTOOLS (July 19, 1999)

Other clearances for product code NGE

  • K020808 — FERTILITE OV (September 23, 2002)
  • K990223 — MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR (February 24, 1999)
  • K981207 — CLEARPLAN EASY FERTILITY MONITOR (October 28, 1998)
  • K863121 — PEAK OVULATION PREDICTOR (October 14, 1986)
  • K850579 — CUE FERTILITY MONITOR (March 22, 1985)