AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K072686
Device Name AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
the technology park
dundee, scotland, 

GB

dd2 1xa

Applicant Contact claire dora
Correspondent
AXIS-SHIELD DIAGNOSTICS, LTD.
the technology park
dundee, scotland, 

GB

dd2 1xa

Correspodent Contact claire dora
Regulation Number 864.7470
Classification Product Code
LCP  
Subsequent Product Codes
JIT   JJX  
Date Received 09/24/2007
Decision Date 03/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No