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FDA 510(k) Application Details - K984126
Device Classification Name
Antigen, Ebv, Capsid
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510(K) Number
K984126
Device Name
Antigen, Ebv, Capsid
Applicant
ZEUS SCIENTIFIC, INC.
200 EVANS WAY
BRANCHBURG, NJ 08876 US
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Contact
MARK J KOPNITSKY
Other 510(k) Applications for this Contact
Regulation Number
866.3235
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Classification Product Code
MCD
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More FDA Info for this Product Code
Date Received
11/18/1998
Decision Date
01/11/1999
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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