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FDA 510(k) Application Details - K981734
Device Classification Name
Antisera, All Types, Escherichia Coli
More FDA Info for this Device
510(K) Number
K981734
Device Name
Antisera, All Types, Escherichia Coli
Applicant
DENKA SEIKEN'S
3-4-2 NIHONBASHI
KAYABACHO, CHUO-KU
TOKYO 103-0025 JP
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Contact
KEVIN MANGAN
Other 510(k) Applications for this Contact
Regulation Number
866.3255
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Classification Product Code
GNA
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More FDA Info for this Product Code
Date Received
05/18/1998
Decision Date
09/22/1998
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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