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FDA 510(k) Application Details - K984186
Device Classification Name
Ferritin, Antigen, Antiserum, Control
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510(K) Number
K984186
Device Name
Ferritin, Antigen, Antiserum, Control
Applicant
NICHOLS INSTITUTE DIAGNOSTICS
33608 ORTEGA HIGHWAY
SAN JUAN CAPISTRANO, CA 92690-6130 US
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Contact
JIMMY WONG
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Regulation Number
866.5340
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Classification Product Code
DBF
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More FDA Info for this Product Code
Date Received
11/23/1998
Decision Date
02/02/1999
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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