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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
510(k) Number K990827
Device Name MICROPLATE NEONATAL GALT ASSAY
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact JULIET CARRARA
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact JULIET CARRARA
Regulation Number862.1315
Classification Product Code
KQP  
Date Received03/12/1999
Decision Date 04/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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