Device Classification Name |
Electrode, Ion Specific, Potassium
|
510(k) Number |
K013373 |
Device Name |
OMNI C ANALYZER |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
JENNIFER TRIBETT |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
JENNIFER TRIBETT |
Regulation Number | 862.1600
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/11/2001 |
Decision Date | 11/02/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|