Device Classification Name |
Acid, Folic, Radioimmunoassay
|
510(k) Number |
K060774 |
Device Name |
FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 |
Applicant |
BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Applicant Contact |
CAROLYN ANDERSON |
Correspondent |
BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Correspondent Contact |
CAROLYN ANDERSON |
Regulation Number | 862.1295
|
Classification Product Code |
|
Date Received | 03/22/2006 |
Decision Date | 04/21/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|