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FDA 510(k)

COPALIS MULTIPLEX EBV ANTIBODY ASSAY

K-Number: K991660 · 1999-06-04

ApplicantDiaSorin, Inc.
Decision Date1999-06-04
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COPALIS MULTIPLEX EBV ANTIBODY ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 1999-06-04 under 510(k) number K991660. 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 COPALIS MULTIPLEX EBV ANTIBODY ASSAY?

COPALIS MULTIPLEX EBV ANTIBODY ASSAY is a medical device that received FDA 510(k) clearance on 1999-06-04. The listed applicant is DiaSorin, Inc.. The 510(k) number is K991660.

When did COPALIS MULTIPLEX EBV ANTIBODY ASSAY receive FDA 510(k) clearance?

COPALIS MULTIPLEX EBV ANTIBODY ASSAY received FDA 510(k) clearance on 1999-06-04, under 510(k) number K991660.

Who is the listed applicant for COPALIS MULTIPLEX EBV ANTIBODY ASSAY?

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

What is the FDA product code for COPALIS MULTIPLEX EBV ANTIBODY ASSAY?

The FDA product code for COPALIS MULTIPLEX EBV ANTIBODY ASSAY is LSE.

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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.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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