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FDA 510(k)

LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)

K-Number: K970761 · 1998-04-09

ApplicantCambridge Diagnostics Ireland, Ltd.
Decision Date1998-04-09
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND) is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Diagnostics Ireland, Ltd.. It received FDA 510(k) clearance on 1998-04-09 under 510(k) number K970761. 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 LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)?

LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND) is a medical device that received FDA 510(k) clearance on 1998-04-09. The listed applicant is Cambridge Diagnostics Ireland, Ltd.. The 510(k) number is K970761.

When did LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND) receive FDA 510(k) clearance?

LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND) received FDA 510(k) clearance on 1998-04-09, under 510(k) number K970761.

Who is the listed applicant for LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)?

The FDA 510(k) record lists Cambridge Diagnostics Ireland, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)?

The FDA product code for LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND) is LSR.

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Other records listing Cambridge Diagnostics Ireland, Ltd. 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.

K013907INVERNESS MEDICAL EARLY PREGNANCY TESTK970768HUMAN LYME IGM WESTERN BLOT KITK955903SELFCARE EARLY PREGNANCY TEST

Related Devices (Code: LSR)

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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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