FDA 510(k) Application Details - K012352

Device Classification Name	More FDA Info for this Device
510(K) Number	K012352
Device Name	SQA, SPERM QUALITY ANALYZER
Applicant	MEDICAL ELECTRONIC SYSTEMS, LLC 6363 GREENWICH DR. SUITE 220 SAN DIEGO, CA 92122 US Other 510(k) Applications for this Company
Contact	Erika B Ammirati Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2001
Decision Date	09/21/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review