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FDA 510(k)

ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA

K-Number: K930020 · 1993-07-16

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1993-07-16
Product CodeLJN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1993-07-16 under 510(k) number K930020. The device is classified under product code LJN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA?

ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA is a medical device that received FDA 510(k) clearance on 1993-07-16. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K930020.

When did ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA receive FDA 510(k) clearance?

ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA received FDA 510(k) clearance on 1993-07-16, under 510(k) number K930020.

Who is the listed applicant for ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA?

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

What is the FDA product code for ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA?

The FDA product code for ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA is LJN.

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Other records listing Ortho Diagnostic Systems, 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.

K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEK951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATEK963902QUANTITATIVE FIBRINOGEN ASSAYK950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)K950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

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Related Devices (Code: LJN)

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.

K123021BIOPLEX 2200 EBV IGM KITBio-Rad LaboratoriesK073381PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600MFocus Diagnostics, Inc.K042092ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEMZeus Scientific, Inc.K033780MODIFICATION TO SERAQUEST VCA IGMQuest Intl., Inc.K990977SERAQUEST EB VAC IGMQuest Intl., Inc.K991459COPALIS EBV-M ANTIBODY ASSAYDiaSorin, 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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