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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 K950481
Device Name NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT
Applicant
ISOLAB, INC.
BOX 4350
AKRON,  OH  44321
Applicant Contact JANET PERKINS
Correspondent
ISOLAB, INC.
BOX 4350
AKRON,  OH  44321
Correspondent Contact JANET PERKINS
Regulation Number862.1310
Classification Product Code
JIA  
Subsequent Product Code
JJX  
Date Received02/03/1995
Decision Date 02/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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