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FDA 510(k)

BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM

K-Number: K965131 · 1997-03-26

ApplicantWampole Laboratories
Decision Date1997-03-26
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wampole Laboratories. It received FDA 510(k) clearance on 1997-03-26 under 510(k) number K965131. 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 BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM?

BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-26. The listed applicant is Wampole Laboratories. The 510(k) number is K965131.

When did BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM receive FDA 510(k) clearance?

BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM received FDA 510(k) clearance on 1997-03-26, under 510(k) number K965131.

Who is the listed applicant for BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM?

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

What is the FDA product code for BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM?

The FDA product code for BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM is LSR.

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Other records listing Wampole Laboratories 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.

K965129BORRELIA BURGDORFERI IGM ELISA TEST SYSTEMK911444RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEMK882896ONE-STEP HCGK883004MONO-PLUS(TM)K875101VIROGEN CMV ANTIBODY TESTK875161MAT (TM) MICROALBUMIN 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.

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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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