ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS


Device Classification Name

urinary homocystine (nonquantitative) test system

510(k) Number K073640
Device Name ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND 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 862.1377
Classification Product Code
LPS  
Subsequent Product Codes
JIT   JJX  
Date Received 12/26/2007
Decision Date 04/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No