Device Classification Name |
System, Test, Anticardiolipin Immunological
|
510(k) Number |
K001981 |
Device Name |
DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 |
Applicant |
AXIS-SHIELD LTD. |
THE TECHNOLOGY PARK |
DUNDEE, TAYSIDE, SCOTLAND,
GB
DD21XA
|
|
Applicant Contact |
EILEEN MCCAFFERTY |
Correspondent |
AXIS-SHIELD LTD. |
THE TECHNOLOGY PARK |
DUNDEE, TAYSIDE, SCOTLAND,
GB
DD21XA
|
|
Correspondent Contact |
EILEEN MCCAFFERTY |
Regulation Number | 866.5660
|
Classification Product Code |
|
Date Received | 06/29/2000 |
Decision Date | 08/21/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|