Device Classification Name |
fluorescent immunoassay gentamicin
|
510(k) Number |
K801084 |
Device Name |
CYBREX GENTAMICIN |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Regulation Number | 862.3450
|
Classification Product Code |
|
Date Received | 05/07/1980 |
Decision Date | 05/23/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|