Device Classification Name |
Electrode, Ion Specific, Potassium
|
510(k) Number |
K042291 |
Device Name |
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS |
Applicant |
BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD.,W-104 |
P.O. BOX 8000 |
BREA,
CA
92822 -8000
|
|
Applicant Contact |
MARY BETH TANG |
Correspondent |
BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD.,W-104 |
P.O. BOX 8000 |
BREA,
CA
92822 -8000
|
|
Correspondent Contact |
MARY BETH TANG |
Regulation Number | 862.1600
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/24/2004 |
Decision Date | 11/12/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|