| 510(k) Number |
K790362 |
| Device Name |
I BRADYKININ & ANTI-BRADYKININ ANTISERUM |
| Applicant |
| Cambridge Nuclear Corp. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Cambridge Nuclear Corp. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Date Received | 02/22/1979 |
| Decision Date | 04/23/1979 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Immunology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|