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FDA 510(k)

IMMUNETICS C6 LYME ELISA KIT

K-Number: K003754 · 2001-05-10

ApplicantImmunetics, Inc.
Decision Date2001-05-10
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNETICS C6 LYME ELISA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immunetics, Inc.. It received FDA 510(k) clearance on 2001-05-10 under 510(k) number K003754. 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 IMMUNETICS C6 LYME ELISA KIT?

IMMUNETICS C6 LYME ELISA KIT is a medical device that received FDA 510(k) clearance on 2001-05-10. The listed applicant is Immunetics, Inc.. The 510(k) number is K003754.

When did IMMUNETICS C6 LYME ELISA KIT receive FDA 510(k) clearance?

IMMUNETICS C6 LYME ELISA KIT received FDA 510(k) clearance on 2001-05-10, under 510(k) number K003754.

Who is the listed applicant for IMMUNETICS C6 LYME ELISA KIT?

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

What is the FDA product code for IMMUNETICS C6 LYME ELISA KIT?

The FDA product code for IMMUNETICS C6 LYME ELISA KIT is LSR.

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Other records listing Immunetics, 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.

K040407QUICKELISA ANTHRAX-PA KITK991063QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024K991062QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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