Home / 510(k) Clearances / K870999

510(k) K870999

GENDER CHOICE INFORMATION KIT, FEMALE AND MALE by Procare C/O Wiley, Rein & Fielding — Product Code LHD

K870999 is an FDA 510(k) premarket notification submitted by Procare C/O Wiley, Rein & Fielding for the device "GENDER CHOICE INFORMATION KIT, FEMALE AND MALE". The FDA issued a decision of Substantially Equivalent on Jul 14, 1987. The device falls under product code LHD (Device, Fertility Diagnostic, Proceptive), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 14, 1987
Date Received
Mar 11, 1987
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

  • K200163 — Ava Fertility Tracker (Jan 19, 2021)
  • K122337 — OVUSENSE (Aug 6, 2013)
  • K102499 — DUOFERTILITY (Dec 20, 2011)
  • K050094 — LADY COMP USA (Apr 20, 2006)
  • K030961 — MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 (Sep 12, 2003)
  • K021978 — PETIT SOPHIA (Apr 8, 2003)
  • K002726 — TCOYF FERTILITY SOFTWARE VERSION 1.0 (Apr 6, 2001)
  • K952756 — MEDI-AID BASAL THERMOMETER (Sep 25, 1995)
  • K945427 — B-D DIGITAL THERMOMETER (Jun 15, 1995)
  • K904211 — BIOSELF 2000 FERTILITY INDICATOR (Oct 14, 1992)

FDA data resources