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FDA 510(k) Application Details - K042494
Device Classification Name
Complement C3, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K042494
Device Name
Complement C3, Antigen, Antiserum, Control
Applicant
ORTHO-CLINICAL DIAGNOSTICS
100 INDIGO CREEK DR.
ROCHESTER, NY 14626-5101 US
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Contact
Darlene J Phillips
Other 510(k) Applications for this Contact
Regulation Number
866.5240
More FDA Info for this Regulation Number
Classification Product Code
CZW
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More FDA Info for this Product Code
Date Received
09/14/2004
Decision Date
10/19/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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