AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K111964
Device Name AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY
Applicant
AALTO SCIENTIFIC LTD.
1959 kellogg ave.
carlsbad, 
CA 
92008

Applicant Contact dessi lyakov
Correspondent
AALTO SCIENTIFIC LTD.
1959 kellogg ave.
carlsbad, 
CA 
92008

Correspodent Contact dessi lyakov
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 07/11/2011
Decision Date 03/02/2012
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