FDA 510(k) Application Details - K970093

Device Classification Name	1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine   More FDA Info for this Device
510(K) Number	K970093
Device Name	1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine
Applicant	ASTORIA-PACIFIC,INC. 14600 S.E. 82ND DR. CLACKAMAS, OR 97015-0830 US Other 510(k) Applications for this Company
Contact	RAYMOND L PAVITT Other 510(k) Applications for this Contact
Regulation Number	862.1730   More FDA Info for this Regulation Number
Classification Product Code	CDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/1997
Decision Date	03/19/1998
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