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FDA 510(k) Application Details - K984175
Device Classification Name
System, Test, Anticardiolipin Immunological
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510(K) Number
K984175
Device Name
System, Test, Anticardiolipin Immunological
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
866.5660
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Classification Product Code
MID
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More FDA Info for this Product Code
Date Received
11/20/1998
Decision Date
12/17/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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