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FDA 510(k) Application Details - K051928
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
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510(K) Number
K051928
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
RADIOMETER MEDICAL APS
AKANDEVEJ 21
BRONSHOJ DK-2700 DK
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Contact
LENE M MARNAES
Other 510(k) Applications for this Contact
Regulation Number
862.1660
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Classification Product Code
JJY
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More FDA Info for this Product Code
Date Received
07/18/2005
Decision Date
10/12/2005
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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