Device Classification Name |
calibrator, secondary
|
510(k) Number |
K042490 |
Device Name |
ELECSYS FOLATE II CALSET II |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
KAY A TAYLOR MT (ASCP), RAC |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
KAY A TAYLOR MT (ASCP), RAC |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 09/14/2004 |
Decision Date | 09/30/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|