RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K023763
Device Name RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
Original Applicant
RANDOX LABORATORIES, LTD.
ardmore, diamond road
crumlin, co. antrim, 

GB

bt29 4qy

Original Contact lynne hamilton
Regulation Number 864.7470
Classification Product Code
LCP  
Subsequent Product Codes
JIT   JJX  
Date Received 11/08/2002
Decision Date 01/13/2003
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