MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K112834
Device Name MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
Applicant
VERICHEM LABORATORIES, INC.
90 narragansett ave.
providence, 
RI 
02907

Applicant Contact anthony james dimonte
Correspondent
VERICHEM LABORATORIES, INC.
90 narragansett ave.
providence, 
RI 
02907

Correspodent Contact anthony james dimonte
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 09/28/2011
Decision Date 03/28/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No