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FDA 510(k) Application Details - K992791
Device Classification Name
System, Test, Thyroid Autoantibody
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510(K) Number
K992791
Device Name
System, Test, Thyroid Autoantibody
Applicant
BRAHMS DIAGNOSTICA, LLC.
29 SOUTH PEACHTREE ST.
NORCROSS, GA 30071 US
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Contact
H. LEE HERRON
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Regulation Number
866.5870
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Classification Product Code
JZO
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More FDA Info for this Product Code
Date Received
08/19/1999
Decision Date
11/12/1999
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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