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FDA 510(k)

EBV LGG ELISA TEST

K-Number: K941198 · 1995-08-23

ApplicantGull Laboratories, Inc.
Decision Date1995-08-23
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV LGG ELISA 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 1995-08-23 under 510(k) number K941198. 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 LGG ELISA TEST?

EBV LGG ELISA TEST is a medical device that received FDA 510(k) clearance on 1995-08-23. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K941198.

When did EBV LGG ELISA TEST receive FDA 510(k) clearance?

EBV LGG ELISA TEST received FDA 510(k) clearance on 1995-08-23, under 510(k) number K941198.

Who is the listed applicant for EBV LGG ELISA 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 LGG ELISA TEST?

The FDA product code for EBV LGG ELISA TEST is LSE.

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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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