Device Classification Name |
enzyme immunoassay, tracrolimus
|
510(k) Number |
K070820 |
Device Name |
ARCHITECT TACROLIMUS: MODEL 1L77 |
Applicant |
FUJIREBIO DIAGNOSTICS, INC. |
201 GREAT VALLEY PKWY. |
MALVERN,
PA
19355 -1307
|
|
Applicant Contact |
DIANA DICKSON |
Correspondent |
FUJIREBIO DIAGNOSTICS, INC. |
201 GREAT VALLEY PKWY. |
MALVERN,
PA
19355 -1307
|
|
Correspondent Contact |
DIANA DICKSON |
Regulation Number | 862.1678
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/26/2007 |
Decision Date | 08/01/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|