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FDA 510(k) Application Details - K081300
Device Classification Name
Colorimetric Method, Lipoproteins
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510(K) Number
K081300
Device Name
Colorimetric Method, Lipoproteins
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
MS 514, PO BOX 6101
NEWARK, DE 19714-6101 US
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Contact
PAMELA A JURGA
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Regulation Number
862.1475
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Classification Product Code
JHM
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More FDA Info for this Product Code
Date Received
05/08/2008
Decision Date
07/02/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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