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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 K943684
Device Name HICHEM ENZYME VERIFIER KIT
Applicant
Hi Chem, Inc.
231 N. Puente St.
P.O. Box 1599
Brea,  CA  92621
Applicant Contact WYNN STOCKING
Correspondent
Hi Chem, Inc.
231 N. Puente St.
P.O. Box 1599
Brea,  CA  92621
Correspondent Contact WYNN STOCKING
Regulation Number862.1660
Classification Product Code
JJT  
Date Received07/29/1994
Decision Date 10/04/1994
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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