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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K901115
Device Name MULTICONSTITUENT SERUM RANGE LINEARITY #88234
Applicant
Hichem Diagnostics
231 N. Puente St.
Brea,  CA  92621
Applicant Contact BENTLEY TAM
Correspondent
Hichem Diagnostics
231 N. Puente St.
Brea,  CA  92621
Correspondent Contact BENTLEY TAM
Regulation Number862.1660
Classification Product Code
JJY  
Date Received03/09/1990
Decision Date 04/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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