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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, Phenobarbital
510(k) Number K935568
Device Name PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS
Applicant
Baxter Diagnostics, Inc.
P.O. Box 25101
Santa Ana,  CA  92799
Applicant Contact SCOTT BEGGINS
Correspondent
Baxter Diagnostics, Inc.
P.O. Box 25101
Santa Ana,  CA  92799
Correspondent Contact SCOTT BEGGINS
Regulation Number862.3660
Classification Product Code
DLZ  
Date Received11/18/1993
Decision Date 03/11/1994
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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