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FDA 510(k) Application Details - K030067
Device Classification Name
Kit, Serological, Positive Control
More FDA Info for this Device
510(K) Number
K030067
Device Name
Kit, Serological, Positive Control
Applicant
ORTHO-CLINICAL DIAGNOSTICS
100 INDIGO CREEK DR.
ROCHESTER, NY 14626-5101 US
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Contact
SARAH PARSONS
Other 510(k) Applications for this Contact
Regulation Number
862.1660
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Classification Product Code
MJX
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More FDA Info for this Product Code
Date Received
01/07/2003
Decision Date
01/17/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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