FDA 510(k) Application Details - K970919

Device Classification Name	Acid, Uric, Uricase (Colorimetric)   More FDA Info for this Device
510(K) Number	K970919
Device Name	Acid, Uric, Uricase (Colorimetric)
Applicant	BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 BREA, CA 92622-8000 US Other 510(k) Applications for this Company
Contact	SHERI HALL Other 510(k) Applications for this Contact
Regulation Number	862.1775   More FDA Info for this Regulation Number
Classification Product Code	KNK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/1997
Decision Date	05/21/1997
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