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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K855196
Device Name CLEANING REAGENT KIT PRODUCT NO 88194
Applicant
Hi Chem, Inc.
P.O. Box 1599
Brea,  CA  92622
Applicant Contact ANDREW ESTRADA
Correspondent
Hi Chem, Inc.
P.O. Box 1599
Brea,  CA  92622
Correspondent Contact ANDREW ESTRADA
Regulation Number862.2160
Classification Product Code
JJE  
Date Received12/26/1985
Decision Date 01/22/1986
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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