Device Classification Name |
electrode, ion specific, potassium
|
510(k) Number |
K083680 |
Device Name |
VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 |
Applicant |
Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. |
MC 00882 |
ROCHESTER,
NY
14626 -5101
|
|
Applicant Contact |
MARLENE A HANNA |
Correspondent |
Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. |
MC 00882 |
ROCHESTER,
NY
14626 -5101
|
|
Correspondent Contact |
MARLENE A HANNA |
Regulation Number | 862.1600
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/12/2008 |
Decision Date | 02/27/2009 |
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
|
|
|