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510(k) K850579

CUE FERTILITY MONITOR by Zetek, Inc. — Product Code NGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1985
Date Received
February 13, 1985
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 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)
  • K973860 — OVULON MONITOR (January 7, 1998)
  • K863121 — PEAK OVULATION PREDICTOR (October 14, 1986)