| Device Classification Name |
Susceptibility Test Powders, Antimicrobial
|
| 510(k) Number |
K822866 |
| Device Name |
MOXALACTAM |
| Applicant |
| Lilly Research Laboratories |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Correspondent |
| Lilly Research Laboratories |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Regulation Number | 866.1640 |
| Classification Product Code |
|
| Date Received | 09/27/1982 |
| Decision Date | 12/28/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Microbiology
|
| 510k Review Panel |
Microbiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|