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FDA 510(k)

PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G

K-Number: K073382 · 2008-07-28

ApplicantFocus Diagnostics, Inc.
Decision Date2008-07-28
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G is the device name listed in this FDA 510(k) record. The listed applicant is Focus Diagnostics, Inc.. It received FDA 510(k) clearance on 2008-07-28 under 510(k) number K073382. 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 PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G?

PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G is a medical device that received FDA 510(k) clearance on 2008-07-28. The listed applicant is Focus Diagnostics, Inc.. The 510(k) number is K073382.

When did PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G receive FDA 510(k) clearance?

PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G received FDA 510(k) clearance on 2008-07-28, under 510(k) number K073382.

Who is the listed applicant for PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G?

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

What is the FDA product code for PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G?

The FDA product code for PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G is LSE.

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Other records listing Focus Diagnostics, Inc. as applicant

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Related Devices (Code: LSE)

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.

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.K062213BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories, Inc.K062211BIOPLEX 2200 EBV IGG PANEL FOR 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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