FDA 510(k) Application Details - K040975

Device Classification Name	Ph Rate Measurement, Carbon-Dioxide   More FDA Info for this Device
510(K) Number	K040975
Device Name	Ph Rate Measurement, Carbon-Dioxide
Applicant	GENCHEM, INC. 471 W. LAMBERT RD., SUITE 107 BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	C.C. ALLAIN Other 510(k) Applications for this Contact
Regulation Number	862.1160   More FDA Info for this Regulation Number
Classification Product Code	JFL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2004
Decision Date	12/27/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review