Device Classification Name |
enzymatic, carbon-dioxide
|
510(k) Number |
K060295 |
Device Name |
CARBON DIOXIDE |
Applicant |
ABBOTT LABORATORIES |
1921 HURD DR. |
IRVING,
TX
75038
|
|
Applicant Contact |
LINDA MORRIS |
Correspondent |
ABBOTT LABORATORIES |
1921 HURD DR. |
IRVING,
TX
75038
|
|
Correspondent Contact |
LINDA MORRIS |
Regulation Number | 862.1160
|
Classification Product Code |
|
Date Received | 02/06/2006 |
Decision Date | 05/04/2006 |
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
|
|
|