DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K080618
Device Name DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
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 864.7470
Classification Product Code
LCP  
Subsequent Product Code
CGA  
Date Received 03/05/2008
Decision Date 05/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No