Audit MicroControls Linearity LQ Cystatin-C


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K143571
Device Name Audit MicroControls Linearity LQ Cystatin-C
Applicant
AALTO SCIENTIFIC, LTD.
1959 kellogg ave.
carlsbad, 
CA 
92008

Applicant Contact robert burda
Correspondent
AALTO SCIENTIFIC, LTD.
1959 kellogg ave.
carlsbad, 
CA 
92008

Correspodent Contact robert burda
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 12/17/2014
Decision Date 01/23/2015
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