FDA 510(k) Application Details - K955630

Device Classification Name	Electrolyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K955630
Device Name	Electrolyte Controls (Assayed And Unassayed)
Applicant	BIONOSTICS, INC. 2 CRAIG RD. ACTON, MA 01720 US Other 510(k) Applications for this Company
Contact	BRUCE R WILLIAMS Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/1995
Decision Date	03/01/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review