| Device Classification Name |
Culture Media, Selective And Differential
|
| 510(k) Number |
K870502 |
| Device Name |
CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS |
| Applicant |
| Clinical Convenience Products, Inc. |
| P.O. Box 7773 |
|
Madison,
WI
53707
|
|
| Applicant Contact |
TODD STYKA |
| Correspondent |
| Clinical Convenience Products, Inc. |
| P.O. Box 7773 |
|
Madison,
WI
53707
|
|
| Correspondent Contact |
TODD STYKA |
| Regulation Number | 866.2360 |
| Classification Product Code |
|
| Date Received | 02/04/1987 |
| Decision Date | 02/26/1987 |
| 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
|
|
|