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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 K922547
Device Name QUANTASE PHENYLALANINE ASSAY
Applicant
Porton Cambridge , Ltd.
Lanwades Business Park
Kennett, Newmarket
Cb8 7pw, United Kingdom,  GB
Applicant Contact DR. G SHEPPARD
Correspondent
Porton Cambridge , Ltd.
Lanwades Business Park
Kennett, Newmarket
Cb8 7pw, United Kingdom,  GB
Correspondent Contact DR. G SHEPPARD
Regulation Number862.1555
Classification Product Code
JNB  
Date Received06/01/1992
Decision Date 10/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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