Borrelia B31 ViraChip IgM Test Kit
FDA 510(k) K163695 · Viramed Biotech AG
510(k) numberK163695
Submission
- Device name
- Borrelia B31 ViraChip IgM Test Kit
- Applicant
- Viramed Biotech AG
Planegg, DE - Received
- December 28, 2016
- Decision date
- August 22, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LSR – Reagent, Borrelia Serological Reagent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3830
- Specialty
- Microbiology
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More from Gold Standard Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K220016 | Viramed Borrela All-In-One ViraChip Test KitLSR · Traditional | 08/19/2022SE |
| K163504 | Borrelia B31 ViraChip IgG Test KitLSR · Traditional | 07/12/2017SE |
| K092693 | Viramed Biotech AG Borrelia B31 Igg Virastripe, Model V-BbsgusLSR · Traditional | 11/25/2009SE |
| K082329 | Viramed Biotech AG Borrelia B31 Igm VirastripeLSR · Traditional | 08/05/2009SE |
| K051169 | Biramed Biotech Borrelia B31 Igm VirablotLSR · Traditional | 08/11/2005SE |
| K051071 | Viramed Biotech Borrelia B31 Igg VirablotLSR · Traditional | 08/11/2005SE |
Questions and answers
When was Borrelia B31 ViraChip IgM Test Kit cleared by the FDA?
Borrelia B31 ViraChip IgM Test Kit (K163695) received a 510(k) decision of Substantially Equivalent on August 22, 2017, 237 days after the submission was received.
What is the product code of K163695?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.