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FDA 510(k) Application Details - K140554
Device Classification Name
System, Test, Vitamin D
More FDA Info for this Device
510(K) Number
K140554
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
MICK HENDERSON
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
03/04/2014
Decision Date
12/19/2014
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
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