Device Classification Name |
enzymatic, carbon-dioxide
|
510(k) Number |
K131546 |
Device Name |
AU BICARBONATE REAGENT |
Applicant |
BECKMAN COULTER IRELAND INC |
250 S. KRAEMER BLVD. E1.SE.01 |
BREA,
CA
92821
|
|
Applicant Contact |
DAVID G DAVIS |
Correspondent |
BECKMAN COULTER IRELAND INC |
250 S. KRAEMER BLVD. E1.SE.01 |
BREA,
CA
92821
|
|
Correspondent Contact |
DAVID G DAVIS |
Regulation Number | 862.1160
|
Classification Product Code |
|
Date Received | 05/29/2013 |
Decision Date | 10/09/2013 |
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
|
|
|