Virtran Viral Tranporter
FDA 510(k) K851378 · Diagnon Corp.
510(k) numberK851378
Submission
- Device name
- Virtran Viral Tranporter
- Applicant
- Diagnon Corp.
Laurel, MD, US - Received
- April 8, 1985
- Decision date
- June 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIO – Device, Specimen Collection
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
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| K070062 | Coproset Salmonella and Shigella, Uriset Preservative Tubes and Swab Set General UseLIO · Traditional | Diesse Diagnostica Senese S.P.A. | 07/30/2007SE |
| K013711 | Bacti-Swab DryLIO · Traditional | Remel Co. | 11/26/2001SE |
| K003761 | Nat - Nucleic Acid TransportLIO · Traditional | Medical Packaging Corp. | 05/31/2001SE |
| K983119 | Entero-Test HP, Model #102-01LIO · Traditional | Hdc Corp. | 03/15/1999SE |
| K981391 | Par-OneLIO · Traditional | Remel, Inc. | 07/14/1998SE |
More from Remel, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K860967 | Virtran Viral Transporter (Modified)JSN · Traditional | 04/04/1986SE |
| K851635 | Diagnon Herpes Immunoperoxidase Typing TestGQL · Traditional | 10/10/1985SE |
| K851377 | Diagnon Monocombo Vitam. B12[57CO]/FOLATE[125I] RaCDD · Traditional | 08/21/1985SE |
| K841302 | Diagnon Folate 125I Ria KitCGN · Traditional | 06/22/1984SE |
| K832717 | Diagnon B12 57CO Ria KitCDD · Traditional | 12/08/1983SE |
Questions and answers
When was Virtran Viral Tranporter cleared by the FDA?
Virtran Viral Tranporter (K851378) received a 510(k) decision of Substantially Equivalent on June 21, 1985, 74 days after the submission was received.
What is the product code of K851378?
The FDA product code is LIO – Device, Specimen Collection, a Class I (low risk) device regulated under 21 CFR 866.2900.