| Device Classification Name |
Culture Media, Propagating Transport
|
| 510(k) Number |
K860967 |
| Device Name |
VIRTRAN VIRAL TRANSPORTER (MODIFIED) |
| Applicant |
| Diagnon Corp. |
| Phair Office Park |
| 1050 W. St. |
|
Laurel,
MD
20707
|
|
| Applicant Contact |
GORDON, PHD |
| Correspondent |
| Diagnon Corp. |
| Phair Office Park |
| 1050 W. St. |
|
Laurel,
MD
20707
|
|
| Correspondent Contact |
GORDON, PHD |
| Regulation Number | 866.2390 |
| Classification Product Code |
|
| Date Received | 03/10/1986 |
| Decision Date | 04/04/1986 |
| 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
|
|
|