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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amyloclastic, Amylase
510(k) Number K895555
Device Name MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)
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 Number862.1070
Classification Product Code
CJA  
Date Received09/06/1989
Decision Date 12/22/1989
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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