FDA 510(k) Application Details - K042519

Device Classification Name	System, Test, Vitamin D   More FDA Info for this Device
510(K) Number	K042519
Device Name	System, Test, Vitamin D
Applicant	IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK BOLDON, TYNE & WEAR NE35 9PD GB Other 510(k) Applications for this Company
Contact	PAUL PUNTIN Other 510(k) Applications for this Contact
Regulation Number	862.1825   More FDA Info for this Regulation Number
Classification Product Code	MRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/2004
Decision Date	12/01/2004
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