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FDA 510(k)

BARTELS LYME DISEASE IGM EIA

K-Number: K922578 · 1992-09-02

ApplicantBaxter Diagnostics, Inc.
Decision Date1992-09-02
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BARTELS LYME DISEASE IGM EIA is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-09-02 under 510(k) number K922578. 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 BARTELS LYME DISEASE IGM EIA?

BARTELS LYME DISEASE IGM EIA is a medical device that received FDA 510(k) clearance on 1992-09-02. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K922578.

When did BARTELS LYME DISEASE IGM EIA receive FDA 510(k) clearance?

BARTELS LYME DISEASE IGM EIA received FDA 510(k) clearance on 1992-09-02, under 510(k) number K922578.

Who is the listed applicant for BARTELS LYME DISEASE IGM EIA?

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

What is the FDA product code for BARTELS LYME DISEASE IGM EIA?

The FDA product code for BARTELS LYME DISEASE IGM EIA is LSR.

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Other records listing Baxter Diagnostics, Inc. as applicant

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Related Devices (Code: LSR)

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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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