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FDA 510(k) Application Details - K983386
Device Classification Name
Antigens, All Groups, Streptococcus Spp.
More FDA Info for this Device
510(K) Number
K983386
Device Name
Antigens, All Groups, Streptococcus Spp.
Applicant
PRINCETON BIOMEDITECH CORP.
4242 U.S. RT. 1
MONMOUTH JUNCTION, NJ 08852-1905 US
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Contact
JEMO KANG
Other 510(k) Applications for this Contact
Regulation Number
866.3740
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Classification Product Code
GTY
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More FDA Info for this Product Code
Date Received
09/26/1998
Decision Date
11/25/1998
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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