FDA 510(k)

Viramed Borrela All-In-One ViraChip Test Kit

K-Number: K220016 · 2022-08-19

Decision Date2022-08-19

Product CodeLSR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Viramed Borrela All-In-One ViraChip Test Kit is a medical device manufactured by Viramed Biotech AG. It received FDA 510(k) clearance on 2022-08-19 under approval number K220016. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Viramed Borrela All-In-One ViraChip Test Kit?

Viramed Borrela All-In-One ViraChip Test Kit is a medical device that received FDA 510(k) clearance on 2022-08-19. It is manufactured by Viramed Biotech AG. The 510(k) number is K220016.

When was Viramed Borrela All-In-One ViraChip Test Kit approved by the FDA?

Viramed Borrela All-In-One ViraChip Test Kit received FDA 510(k) clearance on 2022-08-19, under approval number K220016.

What company makes Viramed Borrela All-In-One ViraChip Test Kit?

Viramed Borrela All-In-One ViraChip Test Kit is manufactured by Viramed Biotech AG.

What is the FDA product code for Viramed Borrela All-In-One ViraChip Test Kit?

The FDA product code for Viramed Borrela All-In-One ViraChip Test Kit is LSR.

Other Devices by Viramed Biotech AG

K163695Borrelia B31 ViraChip IgM Test Kit K163504Borrelia B31 ViraChip IgG Test Kit

Related Devices (Code: LSR)

K161513Anti-Borrelia burgdorferi US Westernblot (IgG)Euroimmun US K172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)Euroimmun Us, Inc. K172254Lyme B. burgdorferi (IgM) MarStripe TestTrinity Biotech K163713Sofia Lyme FIA, Sofia Lyme Control SetQuidel Corporation K163695Borrelia B31 ViraChip IgM Test KitViramed Biotech AG K163504Borrelia B31 ViraChip IgG Test KitViramed Biotech AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.