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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 K902673
Device Name HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND
Applicant
Hi Chem, Inc.
231 N. Puente St.
P.O. Box 1599
Brea,  CA  92621
Applicant Contact BENTLEY TAM
Correspondent
Hi Chem, Inc.
231 N. Puente St.
P.O. Box 1599
Brea,  CA  92621
Correspondent Contact BENTLEY TAM
Regulation Number862.1660
Classification Product Code
JJY  
Date Received06/18/1990
Decision Date 07/17/1990
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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