CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA


Device Classification Name

enzymatic esterase–oxidase, cholesterol

510(k) Number K080623
Device Name CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
Applicant
JAS Diagnostics, Inc.
7220 nw 58th st.
miami, 
FL 
33166

Applicant Contact samuel burgos
Correspondent
JAS Diagnostics, Inc.
7220 nw 58th st.
miami, 
FL 
33166

Correspodent Contact samuel burgos
Regulation Number 862.1175
Classification Product Code
CHH  
Subsequent Product Code
CDT  
Date Received 03/05/2008
Decision Date 11/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No