FDA 510(k) Application Details - K000915

Device Classification Name	Labware, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K000915
Device Name	Labware, Assisted Reproduction
Applicant	HUMAGEN FERTILITY DIAGNOSTICS, INC. 2400 HUNTER'S WAY CHARLOTTESVILLE, VA 22911 US Other 510(k) Applications for this Company
Contact	CINDY SHOWALTER Other 510(k) Applications for this Contact
Regulation Number	884.6160   More FDA Info for this Regulation Number
Classification Product Code	MQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2000
Decision Date	05/12/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review