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FDA 510(k)

EBV-EA TEST

K-Number: K872617 · 1988-01-05

ApplicantGull Laboratories, Inc.
Decision Date1988-01-05
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV-EA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Gull Laboratories, Inc.. It received FDA 510(k) clearance on 1988-01-05 under 510(k) number K872617. 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 EBV-EA TEST?

EBV-EA TEST is a medical device that received FDA 510(k) clearance on 1988-01-05. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K872617.

When did EBV-EA TEST receive FDA 510(k) clearance?

EBV-EA TEST received FDA 510(k) clearance on 1988-01-05, under 510(k) number K872617.

Who is the listed applicant for EBV-EA TEST?

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

What is the FDA product code for EBV-EA TEST?

The FDA product code for EBV-EA TEST is LSE.

Other records listing Gull Laboratories, 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.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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