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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 K984463
Device Name QUANTASE PHE/GAL SCREENING ASSAY
Applicant
QUANTASE LTD.
3 RIVERVIEW BUSINESS PARK
FRIARTON ROAD
PERTH, SCOTLAND,  GB PH2 8DF
Applicant Contact R. STEWART CAMPBELL
Correspondent
QUANTASE LTD.
3 RIVERVIEW BUSINESS PARK
FRIARTON ROAD
PERTH, SCOTLAND,  GB PH2 8DF
Correspondent Contact R. STEWART CAMPBELL
Regulation Number862.1555
Classification Product Code
JNB  
Subsequent Product Codes
JIA   JIX   JJY  
Date Received12/16/1998
Decision Date 02/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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