FDA 510(k) Application Details - K970330

Device Classification Name	Electrode, Ion Specific, Potassium   More FDA Info for this Device
510(K) Number	K970330
Device Name	Electrode, Ion Specific, Potassium
Applicant	DADE INTL., INC. BUILDING 500, MAILBOX 514 P.O. BOX 6101 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	CAROLYN K GEORGE Other 510(k) Applications for this Contact
Regulation Number	862.1600   More FDA Info for this Regulation Number
Classification Product Code	CEM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/28/1997
Decision Date	04/14/1997
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