RANDOX HAEMOGLOBIN A1C


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K021897
Device Name RANDOX HAEMOGLOBIN A1C
Original Applicant
RANDOX LABORATORIES, LTD.
ardmore, diamond road
crumlin, 

IE

bt29 4qy

Original Contact p armstrong
Regulation Number 864.7470
Classification Product Code
LCP  
Date Received 06/10/2002
Decision Date 11/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No