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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K953863
Device Name HICHEM ISE STANDARDS KIT 70011
Applicant
Hichem Diagnostics
231 N. Puente St.
Brea,  CA  92821
Applicant Contact WYNN STOCKING
Correspondent
Hichem Diagnostics
231 N. Puente St.
Brea,  CA  92821
Correspondent Contact WYNN STOCKING
Regulation Number862.1150
Classification Product Code
JIX  
Date Received08/17/1995
Decision Date 09/06/1995
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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