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FDA 510(k) Application Details - K063057
Device Classification Name
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
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510(K) Number
K063057
Device Name
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Applicant
DIAGNOSTIC PRODUCTS CORPORATION
5210 PACIFIC CONCOURSE DR
LOS ANGELES, CA 90045-6900 US
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Contact
DEBORAH L MORRIS
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Regulation Number
866.5270
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Classification Product Code
NQD
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Date Received
10/05/2006
Decision Date
12/22/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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