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FDA 510(k) Application Details - K993250
Device Classification Name
Antibodies, Gliadin
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510(K) Number
K993250
Device Name
Antibodies, Gliadin
Applicant
ZEUS SCIENTIFIC, INC.
200 EVANS WAY
BRANCHBURG, NJ 08876 US
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Contact
MARK J KOPNITSKY
Other 510(k) Applications for this Contact
Regulation Number
866.5750
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Classification Product Code
MST
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More FDA Info for this Product Code
Date Received
09/28/1999
Decision Date
11/12/1999
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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