FDA 510(k) Application Details - K981933

Device Classification Name	Urinalysis Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K981933
Device Name	Urinalysis Controls (Assayed And Unassayed)
Applicant	MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. CAMARILLO, CA 93012-8058 US Other 510(k) Applications for this Company
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	06/02/1998
Decision Date	06/29/1998
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