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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 K993536
Device Name BIO-RAD CODA NEONATAL GALT ASSAY
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547 -1803
Applicant Contact ELIZABETH TANG
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547 -1803
Correspondent Contact ELIZABETH TANG
Regulation Number862.1315
Classification Product Code
KQP  
Date Received10/19/1999
Decision Date 11/04/1999
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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