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FDA 510(k) Application Details - K974429
Device Classification Name
System, Test, C-Reactive Protein
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510(K) Number
K974429
Device Name
System, Test, C-Reactive Protein
Applicant
STANBIO LABORATORY
2930 EAST HOUSTON ST.
SAN ANTONIO, TX 78202 US
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Contact
KIRK JOHNSON
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Regulation Number
866.5270
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Classification Product Code
DCN
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More FDA Info for this Product Code
Date Received
11/24/1997
Decision Date
02/18/1998
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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