FDA 510(k) Application Details - K070207

Device Classification Name	Calibrator, Multi-Analyte Mixture   More FDA Info for this Device
510(K) Number	K070207
Device Name	Calibrator, Multi-Analyte Mixture
Applicant	POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE CANTON, MI 48188 US Other 510(k) Applications for this Company
Contact	RON JAMISON Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2007
Decision Date	04/13/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review