Device Classification Name |
enzymatic method, creatinine
|
510(k) Number |
K093458 |
Device Name |
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 |
Applicant |
BECKMAN COULTER, INC. |
200 S. KRAEMER BOULEVARD |
M/S W-110 |
BREA,
CA
92822 -8000
|
|
Applicant Contact |
MARINE BOYAJIAN |
Correspondent |
BECKMAN COULTER, INC. |
200 S. KRAEMER BOULEVARD |
M/S W-110 |
BREA,
CA
92822 -8000
|
|
Correspondent Contact |
MARINE BOYAJIAN |
Regulation Number | 862.1225
|
Classification Product Code |
|
Date Received | 11/06/2009 |
Decision Date | 12/04/2009 |
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
|
|
|