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FDA 510(k) Application Details - K980885
Device Classification Name
Test, Qualitative And Quantitative Factor Deficiency
More FDA Info for this Device
510(K) Number
K980885
Device Name
Test, Qualitative And Quantitative Factor Deficiency
Applicant
SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE DD2 1SW GB
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Contact
EILEEN MCCAFFERTY
Other 510(k) Applications for this Contact
Regulation Number
864.7290
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Classification Product Code
GGP
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More FDA Info for this Product Code
Date Received
03/09/1998
Decision Date
08/21/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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