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FDA 510(k) Application Details - K993633
Device Classification Name
Antigens, Nontreponemal, All
More FDA Info for this Device
510(K) Number
K993633
Device Name
Antigens, Nontreponemal, All
Applicant
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 CLIFTON RD., N.E.
ATLANTA, GA 30333 US
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Contact
VICTORIA POPE
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Regulation Number
866.3820
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Classification Product Code
GMQ
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More FDA Info for this Product Code
Date Received
10/27/1999
Decision Date
02/23/2000
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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