A1CNOW FOR HOME AND PROFESSIONAL USE


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K033847
Device Name A1CNOW FOR HOME AND PROFESSIONAL USE
Applicant
METRIKA, INC.
510 oakmead pkwy.
sunnyvale, 
CA 
94085 -4022

Applicant Contact erika ammirati
Correspondent
METRIKA, INC.
510 oakmead pkwy.
sunnyvale, 
CA 
94085 -4022

Correspodent Contact erika ammirati
Regulation Number 864.7470
Classification Product Code
LCP  
Date Received 12/11/2003
Decision Date 12/23/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No