Device Classification Name |
calibrator, multi-analyte mixture
|
510(k) Number |
K032287 |
Device Name |
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 |
Applicant |
BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 |
BOX 8000 |
BREA,
CA
92822 -8000
|
|
Applicant Contact |
KIM WALKER |
Correspondent |
BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 |
BOX 8000 |
BREA,
CA
92822 -8000
|
|
Correspondent Contact |
KIM WALKER |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 07/24/2003 |
Decision Date | 08/18/2003 |
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
|
|
|