Device Classification Name |
radioimmunoassay, thyroid-stimulating hormone
|
510(k) Number |
K023093 |
Device Name |
ACCESS HYPERSENSITIVE HTSH ASSAY |
Applicant |
BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Applicant Contact |
DENISE THOMPSON |
Correspondent |
BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Correspondent Contact |
DENISE THOMPSON |
Regulation Number | 862.1690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/18/2002 |
Decision Date | 11/25/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|