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FDA 510(k) Application Details - K982866
Device Classification Name
System, Test, Thyroid Autoantibody
More FDA Info for this Device
510(K) Number
K982866
Device Name
System, Test, Thyroid Autoantibody
Applicant
NICHOLS INSTITUTE DIAGNOSTICS
33051 CALLE AVIADOR
SAN JUAN CAPISTRANO, CA 92675 US
Other 510(k) Applications for this Company
Contact
JIMMY WONG
Other 510(k) Applications for this Contact
Regulation Number
866.5870
More FDA Info for this Regulation Number
Classification Product Code
JZO
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More FDA Info for this Product Code
Date Received
08/14/1998
Decision Date
10/16/1998
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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