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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Methods, Galactose
510(k) Number K990644
Device Name QUANTASE TOTAL GALACTOSE SCREENING ASSAY
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 Number862.1310
Classification Product Code
JIA  
Date Received02/26/1999
Decision Date 06/21/1999
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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