Device Classification Name |
Calibrator, Secondary
|
510(k) Number |
K043095 |
Device Name |
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
P.O. BOX 50416 |
INDIANAPOLIS,
IN
46250 -0457
|
|
Applicant Contact |
KAY A TAYLOR |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
P.O. BOX 50416 |
INDIANAPOLIS,
IN
46250 -0457
|
|
Correspondent Contact |
KAY A TAYLOR |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 11/09/2004 |
Decision Date | 11/23/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|