FDA 510(k) Application Details - K013371

Device Classification Name	Colorimeter, Photometer, Spectrophotometer For Clinical Use   More FDA Info for this Device
510(K) Number	K013371
Device Name	Colorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant	OTSUKA PHARMACEUTICAL CO., LTD. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	CYNTHIA A SINCLAIR Other 510(k) Applications for this Contact
Regulation Number	862.2300   More FDA Info for this Regulation Number
Classification Product Code	JJQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/11/2001
Decision Date	12/21/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review