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FDA 510(k)

IMMUNOWELL BORRELIA (LYME)TEST

K-Number: K911590 · 1991-12-20

ApplicantGeneral Biometrics, Inc.
Decision Date1991-12-20
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOWELL BORRELIA (LYME)TEST is the device name listed in this FDA 510(k) record. The listed applicant is General Biometrics, Inc.. It received FDA 510(k) clearance on 1991-12-20 under 510(k) number K911590. 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 IMMUNOWELL BORRELIA (LYME)TEST?

IMMUNOWELL BORRELIA (LYME)TEST is a medical device that received FDA 510(k) clearance on 1991-12-20. The listed applicant is General Biometrics, Inc.. The 510(k) number is K911590.

When did IMMUNOWELL BORRELIA (LYME)TEST receive FDA 510(k) clearance?

IMMUNOWELL BORRELIA (LYME)TEST received FDA 510(k) clearance on 1991-12-20, under 510(k) number K911590.

Who is the listed applicant for IMMUNOWELL BORRELIA (LYME)TEST?

The FDA 510(k) record lists General Biometrics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMUNOWELL BORRELIA (LYME)TEST?

The FDA product code for IMMUNOWELL BORRELIA (LYME)TEST is LSR.

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Other records listing General Biometrics, Inc. 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.

K924843IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANELK920401IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TESTK920400IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TESTK911627IMMUNODOT BORRELIA (LYME) TESTK911599IMMUNOWELL LYME (P39 RECOMBINANT) TESTK914801IMMUNOWELL DSDNA ANTIBODY TEST

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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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