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FDA 510(k) Application Details - K990207
Device Classification Name
Antibodies, Gliadin
More FDA Info for this Device
510(K) Number
K990207
Device Name
Antibodies, Gliadin
Applicant
ZEUS SCIENTIFIC, INC.
P.O. BOX 38
RARITAN, NJ 08869 US
Other 510(k) Applications for this Company
Contact
MARK K KOPNITSKY
Other 510(k) Applications for this Contact
Regulation Number
866.5750
More FDA Info for this Regulation Number
Classification Product Code
MST
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/21/1999
Decision Date
03/26/1999
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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