A1CNOW FOR HOME USE


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K022661
Device Name A1CNOW FOR HOME USE
Original Applicant
METRIKA, INC.
510 oakmead pkwy.
sunnyvale, 
CA 
94085 -4022

Original Contact erika b ammirati
Regulation Number 864.7470
Classification Product Code
LCP  
Date Received 08/09/2002
Decision Date 12/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No