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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ninhydrin and l-leucyl-l-alanine (fluorimetric), phenylalanine
510(k) Number K961515
Device Name QUANTASE PHENYLALANINE ASSAY
Applicant
SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE,  GB DD2 1SW
Applicant Contact EILEEN MCCAFFERTY
Correspondent
SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE,  GB DD2 1SW
Correspondent Contact EILEEN MCCAFFERTY
Regulation Number862.1555
Classification Product Code
JNB  
Date Received04/10/1996
Decision Date 06/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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