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510(k) K852801

BIOCHRON FERTILITY INDICATOR by Fertil-A-Chron, Inc. — Product Code LHD

K852801 is an FDA 510(k) premarket notification submitted by Fertil-A-Chron, Inc. for the device "BIOCHRON FERTILITY INDICATOR". The FDA issued a decision of Substantially Equivalent on September 19, 1985. The device falls under product code LHD (Device, Fertility Diagnostic, Proceptive), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1985
Date Received
July 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fertility Diagnostic, Proceptive
Device Class
Class U
Regulation Number
Review Panel
OB
Submission Type

Other clearances for product code LHD

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  • K122337 — OVUSENSE (August 6, 2013)
  • K102499 — DUOFERTILITY (December 20, 2011)
  • K050094 — LADY COMP USA (April 20, 2006)
  • K030961 — MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 (September 12, 2003)
  • K021978 — PETIT SOPHIA (April 8, 2003)
  • K002726 — TCOYF FERTILITY SOFTWARE VERSION 1.0 (April 6, 2001)
  • K952756 — MEDI-AID BASAL THERMOMETER (September 25, 1995)
  • K945427 — B-D DIGITAL THERMOMETER (June 15, 1995)
  • K904211 — BIOSELF 2000 FERTILITY INDICATOR (October 14, 1992)

FDA data resources