The following data is part of a premarket notification filed by Diagnon Corp. with the FDA for Virtran Viral Tranporter.
Device ID | K851378 |
510k Number | K851378 |
Device Name: | VIRTRAN VIRAL TRANPORTER |
Classification | Device, Specimen Collection |
Applicant | DIAGNON CORP. PHAIR OFFICE PARK 1050 WEST ST. Laurel, MD 20707 |
Contact | Marie T Perlstein |
Correspondent | Marie T Perlstein DIAGNON CORP. PHAIR OFFICE PARK 1050 WEST ST. Laurel, MD 20707 |
Product Code | LIO |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-08 |
Decision Date | 1985-06-21 |