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FDA 510(k) Application Details - K961204
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
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510(K) Number
K961204
Device Name
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
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
866.3380
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Classification Product Code
LJY
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Date Received
03/27/1996
Decision Date
07/18/1996
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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