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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K913792
Device Name HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL
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
JJX  
Date Received08/23/1991
Decision Date 09/25/1991
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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