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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme immunoassay, carbamazepine
510(k) Number K980283
Device Name VITROS CHEMISTRY PRODUCTS CRBM SLIDES
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14650 -0882
Applicant Contact CHARLES C MORGANSON
Correspondent
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14650 -0882
Correspondent Contact CHARLES C MORGANSON
Regulation Number862.3645
Classification Product Code
KLT  
Date Received01/26/1998
Decision Date 02/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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