Submission Details
| 510(k) Number | K860967 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 10, 1986 |
| Decision Date | April 04, 1986 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
K860967 is an FDA 510(k) clearance for the VIRTRAN VIRAL TRANSPORTER (MODIFIED), a Culture Media, Propagating Transport (Class I — General Controls, product code JSN), submitted by Diagnon Corp. (Laurel, US). The FDA issued a Cleared decision on April 4, 1986, 25 days after receiving the submission on March 10, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K860967 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 10, 1986 |
| Decision Date | April 04, 1986 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSN — Culture Media, Propagating Transport |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.2390 |