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FDA 510(k)

EBNA ENZYME IMMUNOASSAY KIT

K-Number: K951822 · 1996-02-15

ApplicantGranbio, Inc.
Decision Date1996-02-15
Product CodeLLM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBNA ENZYME IMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Granbio, Inc.. It received FDA 510(k) clearance on 1996-02-15 under 510(k) number K951822. 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 ENZYME IMMUNOASSAY KIT?

EBNA ENZYME IMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1996-02-15. The listed applicant is Granbio, Inc.. The 510(k) number is K951822.

When did EBNA ENZYME IMMUNOASSAY KIT receive FDA 510(k) clearance?

EBNA ENZYME IMMUNOASSAY KIT received FDA 510(k) clearance on 1996-02-15, under 510(k) number K951822.

Who is the listed applicant for EBNA ENZYME IMMUNOASSAY KIT?

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

What is the FDA product code for EBNA ENZYME IMMUNOASSAY KIT?

The FDA product code for EBNA ENZYME IMMUNOASSAY KIT is LLM.

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Other records listing Granbio, 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.

K934774UNKNOWNK901156EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUMK901840(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUMK881617INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAYK871298EBNA ACIF ASSAY KITK864347INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA

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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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