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FDA 510(k) Application Details - K961998
Device Classification Name
Antisera, Control For Nontreponemal Tests
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510(K) Number
K961998
Device Name
Antisera, Control For Nontreponemal Tests
Applicant
CONSOLIDATED TECHNOLOGIES, INC.
2170 WOODWARD STREET, STE. 100
AUSTIN, TX 78744-1832 US
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Contact
WILLIAM CONE
Other 510(k) Applications for this Contact
Regulation Number
866.3820
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Classification Product Code
GMP
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More FDA Info for this Product Code
Date Received
05/22/1996
Decision Date
08/08/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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