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FDA 510(k)

EBV-VCA IGM ELISA

K-Number: K915348 · 1992-02-14

ApplicantPharmacia Diagnostics, Inc.
Decision Date1992-02-14
Product CodeLJN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV-VCA IGM ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-02-14 under 510(k) number K915348. 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 EBV-VCA IGM ELISA?

EBV-VCA IGM ELISA is a medical device that received FDA 510(k) clearance on 1992-02-14. The listed applicant is Pharmacia Diagnostics, Inc.. The 510(k) number is K915348.

When did EBV-VCA IGM ELISA receive FDA 510(k) clearance?

EBV-VCA IGM ELISA received FDA 510(k) clearance on 1992-02-14, under 510(k) number K915348.

Who is the listed applicant for EBV-VCA IGM ELISA?

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

What is the FDA product code for EBV-VCA IGM ELISA?

The FDA product code for EBV-VCA IGM ELISA is LJN.

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Other records listing Pharmacia 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.

K921011PHARMACIA CMV IGM ELISAK920702TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNOK914022SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUSK912026DELFIA(R) 17 -OH-PROGESTERON KITK902793RUBELLA IGGK902792TOXOPLASMA GONDII IGG

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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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