| Device Classification Name |
Culture Media, Non-Selective And Non-Differential
|
| 510(k) Number |
K854455 |
| Device Name |
CDC ANAEROBE BLOOD AGAR |
| Applicant |
| R. Kent Richards, Inc. |
| 45 W. Center |
|
Pl. Grove,
UT
84062
|
|
| Applicant Contact |
KENT RICHARDS |
| Correspondent |
| R. Kent Richards, Inc. |
| 45 W. Center |
|
Pl. Grove,
UT
84062
|
|
| Correspondent Contact |
KENT RICHARDS |
| Regulation Number | 866.2300 |
| Classification Product Code |
|
| Date Received | 11/05/1985 |
| Decision Date | 11/18/1985 |
| 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
|
|
|