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FDA 510(k) Application Details - K103325
Device Classification Name
Radioimmunoassay, Parathyroid Hormone
More FDA Info for this Device
510(K) Number
K103325
Device Name
Radioimmunoassay, Parathyroid Hormone
Applicant
IMMUNODIAGNOSTIC SYSTEMS LTD.
10 DIDCOT WAY,
BOLDEN BUSINESS PARK
BOLDON, TYNE & WEAR NE35 9PD GB
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Contact
MICK FENTON
Other 510(k) Applications for this Contact
Regulation Number
862.1545
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Classification Product Code
CEW
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More FDA Info for this Product Code
Date Received
11/12/2010
Decision Date
02/03/2012
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
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