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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescence Polarization Immunoassay, Phenobarbital
510(k) Number K940596
Device Name AXSYM PHENOBARBITAL
Applicant
Abbott Laboratories
Rte. 7, Bond Park
Spartanburg,  SC  29301
Applicant Contact KATHY ZENG
Correspondent
Abbott Laboratories
Rte. 7, Bond Park
Spartanburg,  SC  29301
Correspondent Contact KATHY ZENG
Regulation Number862.3660
Classification Product Code
LGQ  
Date Received02/10/1994
Decision Date 06/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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