Device Classification Name |
fluorometric, cortisol
|
510(k) Number |
K033731 |
Device Name |
AXSYM CORTISOL ASSAY |
Applicant |
FUJIREBIO DIAGNOSTICS, INC. |
201 GREAT VALLEY PKWY. |
MALVERN,
PA
19355
|
|
Applicant Contact |
KIMBERLY PETERSON |
Correspondent |
FUJIREBIO DIAGNOSTICS, INC. |
201 GREAT VALLEY PKWY. |
MALVERN,
PA
19355
|
|
Correspondent Contact |
KIMBERLY PETERSON |
Regulation Number | 862.1205
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/28/2003 |
Decision Date | 02/20/2004 |
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
|
|
|