Device Classification Name |
epstein-barr virus, other |
|||
---|---|---|---|---|
510(k) Number | K992191 | |||
Device Name | ETI-EA-G ASSAY | |||
Applicant |
|
|||
Applicant Contact | judith j smith | |||
Regulation Number | 866.3235 | |||
Classification Product Code |
|
|||
Date Received | 06/28/1999 | |||
Decision Date | 07/12/1999 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Microbiology |
|||
510k Review Panel |
Microbiology |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | Yes | |||
Combination Product |
No |
|||
Recalls | CDRH Recalls |