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FDA 510(k)

Viramed Borrela All-In-One ViraChip Test Kit

K-Number: K220016 · 2022-08-19

ApplicantViramed Biotech AG
Decision Date2022-08-19
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Viramed Borrela All-In-One ViraChip Test Kit is the device name listed in this FDA 510(k) record. The listed applicant is Viramed Biotech AG. It received FDA 510(k) clearance on 2022-08-19 under 510(k) 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. The listed applicant is Viramed Biotech AG. The 510(k) number is K220016.

When did Viramed Borrela All-In-One ViraChip Test Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Viramed Borrela All-In-One ViraChip Test Kit?

The FDA 510(k) record lists Viramed Biotech AG as the applicant. This does not by itself establish the device manufacturer.

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 records listing Viramed Biotech AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163695Borrelia B31 ViraChip IgM Test KitK163504Borrelia B31 ViraChip IgG Test Kit

Related Devices (Code: LSR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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