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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 K970277
Device Name URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)
Applicant
ASTORIA-PACIFIC,INC.
14600 S.E. 82ND DR.
CLACKAMAS,  OR  97015 -0830
Applicant Contact RAYMOND L PAVITT
Correspondent
ASTORIA-PACIFIC,INC.
14600 S.E. 82ND DR.
CLACKAMAS,  OR  97015 -0830
Correspondent Contact RAYMOND L PAVITT
Regulation Number862.1315
Classification Product Code
KQP  
Date Received01/23/1997
Decision Date 12/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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