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FDA 510(k) Application Details - K962825
Device Classification Name
Test, Qualitative And Quantitative Factor Deficiency
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510(K) Number
K962825
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
07/19/1996
Decision Date
11/15/1996
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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