FDA 510(k) Application Details - K964475

Device Classification Name	Calibrator, Primary   More FDA Info for this Device
510(K) Number	K964475
Device Name	Calibrator, Primary
Applicant	OXARC, INC. 716 SOUTH OREGON AVE. PASCO, WA 99301 US Other 510(k) Applications for this Company
Contact	TRAVIS AUGER Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/1996
Decision Date	12/06/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review