FDA 510(k) Application Details - K961864

Device Classification Name	Biuret (Colorimetric), Total Protein   More FDA Info for this Device
510(K) Number	K961864
Device Name	Biuret (Colorimetric), Total Protein
Applicant	TECO DIAGNOSTICS 911 VIA RODEO PLACENTIA, CA 92670 US Other 510(k) Applications for this Company
Contact	K.C. CHEN, PH.D. Other 510(k) Applications for this Contact
Regulation Number	862.1635   More FDA Info for this Regulation Number
Classification Product Code	CEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/1996
Decision Date	10/24/1996
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