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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lipase hydrolysis/glycerol kinase enzyme, triglycerides
510(k) Number K883405
Device Name TRIGLYCERIDES REAGENT (PRODUCT #88218)
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 Number862.1705
Classification Product Code
CDT  
Date Received08/11/1988
Decision Date 09/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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