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FDA 510(k) Application Details - K984135
Device Classification Name
Antisera, Fluorescent, Herpesvirus Hominis 1,2
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510(K) Number
K984135
Device Name
Antisera, Fluorescent, Herpesvirus Hominis 1,2
Applicant
ZEUS SCIENTIFIC, INC.
200 EVANS WAY
BRANCHBURG, NJ 08876 US
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Contact
MARK J KOPNITSKY
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Regulation Number
866.3305
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Classification Product Code
GQL
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Date Received
11/18/1998
Decision Date
05/26/1999
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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