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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 K000754
Device Name QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
Applicant
Quantase , Ltd.
3 Riverview Business Park
Friarton Rd.
Perth, Scotland,  GB PH2 8DF
Applicant Contact R. STEWART CAMPBELL
Correspondent
Quantase , Ltd.
3 Riverview Business Park
Friarton Rd.
Perth, Scotland,  GB PH2 8DF
Correspondent Contact R. STEWART CAMPBELL
Regulation Number862.1555
Classification Product Code
JNB  
Date Received03/08/2000
Decision Date 06/19/2000
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
Recalls CDRH Recalls
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