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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 K993028
Device Name ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90
Applicant
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95161 -9013
Applicant Contact PAUL L ROGERS
Correspondent
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95161 -9013
Correspondent Contact PAUL L ROGERS
Regulation Number862.3645
Classification Product Code
KLT  
Subsequent Product Code
DLJ  
Date Received09/09/1999
Decision Date 01/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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