FDA 510(k) Application Details - K110605

Device Classification Name	Immunoassay, Placental Alpha-1 Microglobulin (Pamg-1)   More FDA Info for this Device
510(K) Number	K110605
Device Name	Immunoassay, Placental Alpha-1 Microglobulin (Pamg-1)
Applicant	CLINICAL INNOVATIONS, LLC 747 WEST 4170 SOUTH MURRAY, UT 84123 US Other 510(k) Applications for this Company
Contact	DEAN WALLACE Other 510(k) Applications for this Contact
Regulation Number	862.1550   More FDA Info for this Regulation Number
Classification Product Code	NQM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/02/2011
Decision Date	11/23/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review