Device Classification Name |
nitroprusside, ketones (urinary, non-quant.)
|
510(k) Number |
K875029 |
Device Name |
ABBOTT BREATH ACETONE ANALYZER |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Applicant Contact |
E NEVALAINEN |
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent Contact |
E NEVALAINEN |
Regulation Number | 862.1435
|
Classification Product Code |
|
Date Received | 12/07/1987 |
Decision Date | 05/27/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|