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FDA 510(k)

IMMUNO DOT BORRELIA DOT BLOT G TEST

K-Number: K953682 · 1996-05-03

ApplicantGenbio
Decision Date1996-05-03
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNO DOT BORRELIA DOT BLOT G TEST is the device name listed in this FDA 510(k) record. The listed applicant is Genbio. It received FDA 510(k) clearance on 1996-05-03 under 510(k) number K953682. 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 IMMUNO DOT BORRELIA DOT BLOT G TEST?

IMMUNO DOT BORRELIA DOT BLOT G TEST is a medical device that received FDA 510(k) clearance on 1996-05-03. The listed applicant is Genbio. The 510(k) number is K953682.

When did IMMUNO DOT BORRELIA DOT BLOT G TEST receive FDA 510(k) clearance?

IMMUNO DOT BORRELIA DOT BLOT G TEST received FDA 510(k) clearance on 1996-05-03, under 510(k) number K953682.

Who is the listed applicant for IMMUNO DOT BORRELIA DOT BLOT G TEST?

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

What is the FDA product code for IMMUNO DOT BORRELIA DOT BLOT G TEST?

The FDA product code for IMMUNO DOT BORRELIA DOT BLOT G TEST is LSR.

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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.

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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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