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FDA 510(k)

PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY

K-Number: K981913 · 1999-02-12

ApplicantChembio Diagnostic Systems, Inc.
Decision Date1999-02-12
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Chembio Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1999-02-12 under 510(k) number K981913. 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 PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY?

PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY is a medical device that received FDA 510(k) clearance on 1999-02-12. The listed applicant is Chembio Diagnostic Systems, Inc.. The 510(k) number is K981913.

When did PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY receive FDA 510(k) clearance?

PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY received FDA 510(k) clearance on 1999-02-12, under 510(k) number K981913.

Who is the listed applicant for PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY?

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

What is the FDA product code for PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY?

The FDA product code for PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY is LSR.

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Other records listing Chembio Diagnostic Systems, Inc. as applicant

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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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