HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE


Device Classification Name

enzymatic esterase–oxidase, cholesterol

510(k) Number K111753
Device Name HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE
Applicant
HITACHI CHEMICAL DIAGNOSTICS, INC.
575 shirlynn court
los altos, 
CA 
94022

Applicant Contact erika b ammirati, rac, mt (ascp)
Correspondent
HITACHI CHEMICAL DIAGNOSTICS, INC.
575 shirlynn court
los altos, 
CA 
94022

Correspodent Contact erika b ammirati, rac, mt (ascp)
Regulation Number 862.1175
Classification Product Code
CHH  
Subsequent Product Codes
CDT   JJE   LBS   MRR  
Date Received 06/22/2011
Decision Date 12/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No