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FDA 510(k)

VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE

K-Number: K082329 · 2009-08-05

ApplicantViramed Biotech AG
Decision Date2009-08-05
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE 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 2009-08-05 under 510(k) number K082329. 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 BIOTECH AG BORRELIA B31 IGM VIRASTRIPE?

VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE is a medical device that received FDA 510(k) clearance on 2009-08-05. The listed applicant is Viramed Biotech AG. The 510(k) number is K082329.

When did VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE receive FDA 510(k) clearance?

VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE received FDA 510(k) clearance on 2009-08-05, under 510(k) number K082329.

Who is the listed applicant for VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE?

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 BIOTECH AG BORRELIA B31 IGM VIRASTRIPE?

The FDA product code for VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE is LSR.

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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.

K220016Viramed Borrela All-In-One ViraChip Test KitK163695Borrelia B31 ViraChip IgM Test KitK163504Borrelia B31 ViraChip IgG Test KitK092693VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUSK051071VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOTK051169BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT

View all 7 devices →

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.

K254295Sofia Lyme FIA; Sofia 2 Campylobacter FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K252627Lyme-ID IgG Test; Bio-ID800Inanovate, Inc.K242872iDart Lyme IgM ImmunoBlot KitId-Fish Technology, Inc.K233367iDart Lyme IgG ImmunoBlot KitId-Fish Technology, Inc.K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control KitZeus ScientificK220016Viramed Borrela All-In-One ViraChip 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.

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