| Device Classification Name |
Culture Media, Anaerobic Transport
|
| 510(k) Number |
K925450 |
| Device Name |
BIONOR TRANSPORTMEDIUM |
| Applicant |
| Skoug Research Corp. |
| P.O. Box 405 |
|
Cambridge,
MA
02141
|
|
| Applicant Contact |
ERIK SKOUG |
| Correspondent |
| Skoug Research Corp. |
| P.O. Box 405 |
|
Cambridge,
MA
02141
|
|
| Correspondent Contact |
ERIK SKOUG |
| Regulation Number | 866.2390 |
| Classification Product Code |
|
| Date Received | 10/28/1992 |
| Decision Date | 06/25/1993 |
| 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
|
|
|