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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Controls (Assayed And Unassayed)
510(k) Number K902321
Device Name HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235)
Applicant
Hichem Diagnostics
231 N. Puente St.
Brea,  CA  92621
Applicant Contact RALPH BOLSTAD
Correspondent
Hichem Diagnostics
231 N. Puente St.
Brea,  CA  92621
Correspondent Contact RALPH BOLSTAD
Regulation Number862.1660
Classification Product Code
JJT  
Date Received05/23/1990
Decision Date 06/28/1990
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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