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FDA 510(k)

BARTELS RUBEOLA IGM EIA

K-Number: K922335 · 1992-09-02

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

Device Summary

BARTELS RUBEOLA 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 K922335. The device is classified under product code LJB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARTELS RUBEOLA IGM EIA?

BARTELS RUBEOLA 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 K922335.

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

BARTELS RUBEOLA IGM EIA received FDA 510(k) clearance on 1992-09-02, under 510(k) number K922335.

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

The FDA product code for BARTELS RUBEOLA IGM EIA is LJB.

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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: LJB)

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.

K974552DIAMEDIX IS-MEASLES IGG TEST SYSTEMDiamedix Corp.K971620QUANTA LITE RUBEOLA (MEASLES) IGGInova Diagnostics, Inc.K922330BARTELS RUBEOLA IGG EIABaxter Diagnostics, Inc.K910290VIRATEST-DIA(TM) MEASLES (RUBEOLA)Virus Reference Laboratory, Inc.K904083RUBEOLA IGM ELISA TESTGull Laboratories, Inc.K903961MEASLES IGG MICROASSAYDiamedix Corp.

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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