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FDA 510(k)

BARTELS TOXOPLASMA IGM EIA

K-Number: K922579 · 1992-09-02

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

Device Summary

BARTELS TOXOPLASMA 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 K922579. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARTELS TOXOPLASMA IGM EIA?

BARTELS TOXOPLASMA 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 K922579.

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

BARTELS TOXOPLASMA IGM EIA received FDA 510(k) clearance on 1992-09-02, under 510(k) number K922579.

Who is the listed applicant for BARTELS TOXOPLASMA 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 TOXOPLASMA IGM EIA?

The FDA product code for BARTELS TOXOPLASMA IGM EIA is LGD.

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Other records listing Baxter Diagnostics, Inc. 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.

K934458DRIED GRAM-POSITIVE MIC/COMBO PANELSK950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCIK935704DRIED GRAM-NEGATIVE MIC//COMBO PANELSK950570STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYK945235DRIED GRAM-POSITIVE MIC/COMBO PANELSK941030DRIED GRAM-NEGATIVE CEFPODOXIME

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Related Devices (Code: LGD)

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.

K242022Access Toxo IgGBeckman Coulter, Inc.K242095Access Toxo IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott LaboratoriesK210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche DiagnosticsK132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIDiaSorin, Inc.

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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