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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, Diphenylhydantoin
510(k) Number K932686
Device Name PARAMAX(R) PHENYTOIN REAGENT
Applicant
Baxter Diagnostics, Inc.
9500 Jeronimo Rd.
Irvine,  CA  92718
Applicant Contact SCOTT BEGGINS
Correspondent
Baxter Diagnostics, Inc.
9500 Jeronimo Rd.
Irvine,  CA  92718
Correspondent Contact SCOTT BEGGINS
Regulation Number862.3350
Classification Product Code
DIP  
Date Received06/03/1993
Decision Date 11/26/1993
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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