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FDA 510(k) Application Details - K960370
Device Classification Name
System, Test, Thyroid Autoantibody
More FDA Info for this Device
510(K) Number
K960370
Device Name
System, Test, Thyroid Autoantibody
Applicant
IMMCO DIAGNOSTICS, INC.
963 KENMORE AVE.
BUFFALO, NY 14223 US
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Contact
RICHARD E GRECO
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
01/25/1996
Decision Date
06/20/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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