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FDA 510(k)

BARTELS EPSTEIN-BARR VIRUS IGG EIA

K-Number: K922332 · 1992-09-02

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

Device Summary

BARTELS EPSTEIN-BARR VIRUS IGG 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 K922332. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARTELS EPSTEIN-BARR VIRUS IGG EIA?

BARTELS EPSTEIN-BARR VIRUS IGG 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 K922332.

When did BARTELS EPSTEIN-BARR VIRUS IGG EIA receive FDA 510(k) clearance?

BARTELS EPSTEIN-BARR VIRUS IGG EIA received FDA 510(k) clearance on 1992-09-02, under 510(k) number K922332.

Who is the listed applicant for BARTELS EPSTEIN-BARR VIRUS IGG 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 EPSTEIN-BARR VIRUS IGG EIA?

The FDA product code for BARTELS EPSTEIN-BARR VIRUS IGG EIA is LSE.

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Other records listing Baxter Diagnostics, Inc. as applicant

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Related Devices (Code: LSE)

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K233606ADVIA Centaur EBV-VCA IgMBiokit, S.A.K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control SetDiaSorin, Inc.K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetDiaSorin, Inc.K091260SERAQUEST EBV EA-D IGG TESTQuest Intl., Inc.K073382PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500GFocus Diagnostics, Inc.K062213BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories, 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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