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FDA 510(k) Application Details - K980059
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
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510(K) Number
K980059
Device Name
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Applicant
QUEST INTL., INC.
1938 N.E. 148TH TERR.
NORTH MIAMI, FL 33181 US
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ROBERT A CORT
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Regulation Number
866.3380
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Classification Product Code
LJY
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Date Received
01/07/1998
Decision Date
04/23/1998
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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