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FDA 510(k)

EBNA IGG ELISA TEST

K-Number: K935730 · 1995-09-19

ApplicantGull Laboratories, Inc.
Decision Date1995-09-19
Product CodeLLM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBNA IGG 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 1995-09-19 under 510(k) number K935730. The device is classified under product code LLM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBNA IGG ELISA TEST?

EBNA IGG ELISA TEST is a medical device that received FDA 510(k) clearance on 1995-09-19. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K935730.

When did EBNA IGG ELISA TEST receive FDA 510(k) clearance?

EBNA IGG ELISA TEST received FDA 510(k) clearance on 1995-09-19, under 510(k) number K935730.

Who is the listed applicant for EBNA IGG 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 EBNA IGG ELISA TEST?

The FDA product code for EBNA IGG ELISA TEST is LLM.

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Other records listing Gull Laboratories, 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.

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Related Devices (Code: LLM)

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.

K233605ADVIA Centaur EBV-EBNA IgGBiokit, S.A.K040120DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYSDiaSorin, Inc.K984133THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K973941IMMUNOWELL EBNA IGG TESTGenbioK980598EBNA-1 IGM ELISA TEST SYSTEMClark Laboratories, Inc.K951549EBNA IGG EIA TEST SYSTEMImmunoprobe, 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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