Device Classification Name |
Diazo Colorimetry, Bilirubin
|
510(k) Number |
K983133 |
Device Name |
TBIL |
Applicant |
ABBOTT LABORATORIES |
1920 HURD DR. |
IRVING,
TX
75038
|
|
Applicant Contact |
LINDA MORRIS |
Correspondent |
ABBOTT LABORATORIES |
1920 HURD DR. |
IRVING,
TX
75038
|
|
Correspondent Contact |
LINDA MORRIS |
Regulation Number | 862.1110
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/08/1998 |
Decision Date | 09/16/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|