| Device Classification Name |
Culture Media, General Nutrient Broth
|
| 510(k) Number |
K790687 |
| Device Name |
BRUCELLA BROTH W/SPS, 6% SORBITOL & CO2 |
| Applicant |
| Gibco Laboratories Life Technologies, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Gibco Laboratories Life Technologies, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 866.2350 |
| Classification Product Code |
|
| Date Received | 04/10/1979 |
| Decision Date | 05/03/1979 |
| 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
|
| Recalls |
CDRH Recalls
|
|
|