The following data is part of a premarket notification filed by Diagnon Corp. with the FDA for Virtran Viral Transporter (modified).
Device ID | K860967 |
510k Number | K860967 |
Device Name: | VIRTRAN VIRAL TRANSPORTER (MODIFIED) |
Classification | Culture Media, Propagating Transport |
Applicant | DIAGNON CORP. PHAIR OFFICE PARK 1050 WEST ST. Laurel, MD 20707 |
Contact | Gordon, Phd |
Correspondent | Gordon, Phd DIAGNON CORP. PHAIR OFFICE PARK 1050 WEST ST. Laurel, MD 20707 |
Product Code | JSN |
CFR Regulation Number | 866.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-10 |
Decision Date | 1986-04-04 |