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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
510(k) Number K861419
Device Name HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE
Applicant
HI CHEM, INC.
231 N. PUENTE ST.
P.O. BOX 1599
BREA,  CA  92621
Applicant Contact ANDREW J ESTRADA
Correspondent
HI CHEM, INC.
231 N. PUENTE ST.
P.O. BOX 1599
BREA,  CA  92621
Correspondent Contact ANDREW J ESTRADA
Regulation Number862.1440
Classification Product Code
CFJ  
Date Received04/15/1986
Decision Date 04/28/1986
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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