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FDA 510(k)

Sofia 2 Lyme FIA, Sofia Lyme Control Set

K-Number: K173496 · 2018-08-30

ApplicantQuidel Corporation
Decision Date2018-08-30
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Sofia 2 Lyme FIA, Sofia Lyme Control Set is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2018-08-30 under 510(k) number K173496. 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 Sofia 2 Lyme FIA, Sofia Lyme Control Set?

Sofia 2 Lyme FIA, Sofia Lyme Control Set is a medical device that received FDA 510(k) clearance on 2018-08-30. The listed applicant is Quidel Corporation. The 510(k) number is K173496.

When did Sofia 2 Lyme FIA, Sofia Lyme Control Set receive FDA 510(k) clearance?

Sofia 2 Lyme FIA, Sofia Lyme Control Set received FDA 510(k) clearance on 2018-08-30, under 510(k) number K173496.

Who is the listed applicant for Sofia 2 Lyme FIA, Sofia Lyme Control Set?

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

What is the FDA product code for Sofia 2 Lyme FIA, Sofia Lyme Control Set?

The FDA product code for Sofia 2 Lyme FIA, Sofia Lyme Control Set is LSR.

Other records listing Quidel Corporation 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.

K231795QuickVue COVID-19 TestK232286Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentK233688Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab SetK230349Lyra RSV+hMPV AssayK230236Lyra Influenza A+B AssayK211342Sofia 2 Campylobacter FIA

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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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