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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K890578
Device Name HI CHEM WASH CONCENTRATE REAGENT #88805
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 Number862.2750
Classification Product Code
JQW  
Date Received02/06/1989
Decision Date 03/10/1989
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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