FDA 510(k) Application Details - K992846

Device Classification Name	Biuret (Colorimetric), Total Protein   More FDA Info for this Device
510(K) Number	K992846
Device Name	Biuret (Colorimetric), Total Protein
Applicant	ELAN HOLDINGS, INC. 231 NORTH PUENTE ST. BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	WYNN STOCKING 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	08/24/1999
Decision Date	10/18/1999
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