Device Classification Name |
single (specified) analyte controls (assayed and unassayed)
|
510(k) Number |
K001458 |
Device Name |
SYNCHRON CONTROL |
Applicant |
BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 |
BOX 8000 |
BREA,
CA
92822 -8000
|
|
Applicant Contact |
LUCINDA STOCKERT |
Correspondent |
BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 |
BOX 8000 |
BREA,
CA
92822 -8000
|
|
Correspondent Contact |
LUCINDA STOCKERT |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 05/10/2000 |
Decision Date | 06/02/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|