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FDA 510(k) Application Details - K984166
Device Classification Name
Acid, Folic, Radioimmunoassay
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510(K) Number
K984166
Device Name
Acid, Folic, Radioimmunoassay
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER, NY 14626-5101 US
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Contact
ANNE ZAVERTNIK
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Regulation Number
862.1295
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Classification Product Code
CGN
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More FDA Info for this Product Code
Date Received
11/20/1998
Decision Date
02/05/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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