Device Classification Name |
system, test, thyroglobulin
|
510(k) Number |
K031269 |
Device Name |
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS |
Applicant |
BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Applicant Contact |
LYNN WEIST |
Correspondent |
BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Correspondent Contact |
LYNN WEIST |
Regulation Number | 866.6010
|
Classification Product Code |
|
Date Received | 04/21/2003 |
Decision Date | 05/02/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|