FDA 510(k) Application Details - K053612

Device Classification Name	Acid Phosphatase, Naphthyl Phosphate   More FDA Info for this Device
510(K) Number	K053612
Device Name	Acid Phosphatase, Naphthyl Phosphate
Applicant	BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 BREA, CA 92822 US Other 510(k) Applications for this Company
Contact	ERI HIRUMI Other 510(k) Applications for this Contact
Regulation Number	862.1020   More FDA Info for this Regulation Number
Classification Product Code	CKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2005
Decision Date	04/26/2006
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