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FDA 510(k) Application Details - K983803
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
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510(K) Number
K983803
Device Name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Applicant
ZEUS SCIENTIFIC, INC.
P.O. BOX 38
RARITAN, NJ 08869 US
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Contact
MARK J KOPNITSKY
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Regulation Number
866.3175
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Classification Product Code
LFZ
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Date Received
10/28/1998
Decision Date
12/14/1998
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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