Device Classification Name |
Acid, Folic, Radioimmunoassay
|
510(k) Number |
K043318 |
Device Name |
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
KAY A TAYLOR |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
KAY A TAYLOR |
Regulation Number | 862.1295
|
Classification Product Code |
|
Date Received | 12/02/2004 |
Decision Date | 12/23/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|