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FDA 510(k) Application Details - K961515
Device Classification Name
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
More FDA Info for this Device
510(K) Number
K961515
Device Name
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
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
862.1555
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Classification Product Code
JNB
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More FDA Info for this Product Code
Date Received
04/10/1996
Decision Date
06/12/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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