FDA 510(k) Application Details - K983432

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K983432
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	CHRONIMED, INC. 10900 RED CIRCLE DR. MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	JEFFREY P HEATON Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/1998
Decision Date	12/17/1998
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