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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 K941433
Device Name HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH
Applicant
Hichem Diagnostics
231 N. Puente St.
Brea,  CA  92621
Applicant Contact WYNN STOCKING
Correspondent
Hichem Diagnostics
231 N. Puente St.
Brea,  CA  92621
Correspondent Contact WYNN STOCKING
Regulation Number862.1660
Classification Product Code
JJX  
Date Received03/24/1994
Decision Date 08/02/1994
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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