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FDA 510(k) Application Details - K963282
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
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510(K) Number
K963282
Device Name
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Applicant
QUEST INTL., INC.
1938 N.E. 148TH TERR.
NORTH MIAMI, FL 33181 US
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Contact
ROBERT A CORT
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Regulation Number
866.3305
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Classification Product Code
LGC
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Date Received
08/21/1996
Decision Date
01/22/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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