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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Controls (Assayed And Unassayed)
510(k) Number K950803
Device Name ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE
Applicant
Isolab, Inc.
Drawer 4350
Akron,  OH  44321
Applicant Contact JANET PERKINS
Correspondent
Isolab, Inc.
Drawer 4350
Akron,  OH  44321
Correspondent Contact JANET PERKINS
Regulation Number862.1660
Classification Product Code
JJT  
Subsequent Product Code
KQP  
Date Received02/21/1995
Decision Date 09/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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