Device Classification Name |
urinary homocystine (nonquantitative) test system
|
510(k) Number |
K083222 |
Device Name |
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 |
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
|
|
Correspondent Contact |
Claire Dora |
Regulation Number | 862.1377
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/03/2008 |
Decision Date | 07/31/2009 |
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
|
Recalls |
CDRH Recalls
|
|
|