Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number |
K041227 |
Device Name |
MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
PO BOX 50457 |
INDIANAPOLIS,
IN
46250 -0457
|
|
Applicant Contact |
THERESA M AMBROSE |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
PO BOX 50457 |
INDIANAPOLIS,
IN
46250 -0457
|
|
Correspondent Contact |
THERESA M AMBROSE |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 05/10/2004 |
Decision Date | 05/27/2004 |
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
|