FDA 510(k) Application Details - K991917

Device Classification Name	Urinalysis Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K991917
Device Name	Urinalysis Controls (Assayed And Unassayed)
Applicant	METRIKA, INC. 510 OAKMEAD PKWY. SUNNYVALE, CA 94085-4022 US Other 510(k) Applications for this Company
Contact	YA-CHEN HSU Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/07/1999
Decision Date	07/12/1999
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