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FDA 510(k)

BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT

K-Number: K051169 · 2005-08-11

ApplicantViramed Biotech AG
Decision Date2005-08-11
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT 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 2005-08-11 under 510(k) number K051169. 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 BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT?

BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT is a medical device that received FDA 510(k) clearance on 2005-08-11. The listed applicant is Viramed Biotech AG. The 510(k) number is K051169.

When did BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT receive FDA 510(k) clearance?

BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT received FDA 510(k) clearance on 2005-08-11, under 510(k) number K051169.

Who is the listed applicant for BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT?

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 BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT?

The FDA product code for BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT 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-BBSGUSK082329VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPEK051071VIRAMED BIOTECH BORRELIA B31 IGG 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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