Viramed Borrela All-In-One ViraChip Test Kit— 510(k) K220016

Name: FDA 510(k) clearance K220016
Creator: U.S. Food and Drug Administration
Published: 2022-08-19

Substantially Equivalent

Viramed Biotech AG

FDA 510(k) clearance K220016 for Viramed Borrela All-In-One ViraChip Test Kit, Substantially Equivalent on 2022-08-19. Applicant: Viramed Biotech AG. Device class: 2.

Clearance details

Applicant: Viramed Biotech AG
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2022-01-05
Decision date: 2022-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Planegg, DE

Download summary PDF View on FDA.gov ↗

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