FDA 510(k) Application Details - K992997

Device Classification Name	Column Chromatography & Color Development, Hydroxyproline   More FDA Info for this Device
510(K) Number	K992997
Device Name	Column Chromatography & Color Development, Hydroxyproline
Applicant	METRIKA, INC. 510 OAKMEAD PKWY. SUNNYVALE, CA 94085-4022 US Other 510(k) Applications for this Company
Contact	Erika B Ammirati Other 510(k) Applications for this Contact
Regulation Number	862.1400   More FDA Info for this Regulation Number
Classification Product Code	JMM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/1999
Decision Date	11/09/1999
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