FDA 510(k) Application Details - K070757

Device Classification Name	Lowry (Colorimetric), Total Protein   More FDA Info for this Device
510(K) Number	K070757
Device Name	Lowry (Colorimetric), Total Protein
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	862.1635   More FDA Info for this Regulation Number
Classification Product Code	JGP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2007
Decision Date	12/04/2007
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