| 510(k) Number |
K822518 |
| Device Name |
CSM BETA-LACTAMASE DISC |
| Applicant |
| Carr-Scarborough Microbiologicals, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Carr-Scarborough Microbiologicals, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Date Received | 08/23/1982 |
| Decision Date | 09/21/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Microbiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|