FDA 510(k) Application Details - K081719

Device Classification Name	System, Hemoglobin, Automated   More FDA Info for this Device
510(K) Number	K081719
Device Name	System, Hemoglobin, Automated
Applicant	STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US Other 510(k) Applications for this Company
Contact	KIRK JOHNSON Other 510(k) Applications for this Contact
Regulation Number	864.5620   More FDA Info for this Regulation Number
Classification Product Code	GKR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/18/2008
Decision Date	07/18/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review