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FDA 510(k) Application Details - K991942
Device Classification Name
Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
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510(K) Number
K991942
Device Name
Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Applicant
COGENT DIAGNOTICS LTD.
PENTLANDS SCIENCE PARK
BUSH LOAN, PENICUIK
MIDLOTHIAN, SCOTLAND EH26 OPL GB
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Contact
DANIELLE M KNIGHT
Other 510(k) Applications for this Contact
Regulation Number
866.5110
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Classification Product Code
MLE
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More FDA Info for this Product Code
Date Received
06/09/1999
Decision Date
08/24/1999
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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