FDA 510(k) Application Details - K040391

Device Classification Name	Diazo Colorimetry, Bilirubin   More FDA Info for this Device
510(K) Number	K040391
Device Name	Diazo Colorimetry, Bilirubin
Applicant	POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. LINCOLN PARK, MI 48146 US Other 510(k) Applications for this Company
Contact	RON JAMISON Other 510(k) Applications for this Contact
Regulation Number	862.1110   More FDA Info for this Regulation Number
Classification Product Code	CIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/17/2004
Decision Date	06/02/2004
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