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FDA 510(k) Application Details - K060929
Device Classification Name
Radioassay, Vitamin B12
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510(K) Number
K060929
Device Name
Radioassay, Vitamin B12
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
862.1810
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Classification Product Code
CDD
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More FDA Info for this Product Code
Date Received
04/05/2006
Decision Date
04/28/2006
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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