| Device Classification Name |
reagents, clostridium difficile toxin |
|||
|---|---|---|---|---|
| 510(k) Number | K991829 | |||
| Device Name | CDTOX A OIA | |||
| Applicant |
|
|||
| Applicant Contact | roger c briden | |||
| Correspondent |
|
|||
| Correspodent Contact | roger c briden | |||
| Regulation Number | 866.2660 | |||
| Classification Product Code |
|
|||
| Date Received | 05/28/1999 | |||
| Decision Date | 11/02/1999 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Microbiology |
|||
| 510k Review Panel |
Microbiology |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |