FDA 510(k) Application Details - K111650

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K111650
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK BOLDON, TYNE & WEAR NE35 9PD GB Other 510(k) Applications for this Company
Contact	MICK FENTON 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	06/13/2011
Decision Date	09/06/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review