AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K112705
Device Name AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
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 09/16/2011
Decision Date 01/24/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No