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FDA 510(k)

UNKNOWN

K-Number: K934774 · 1994-04-20

ApplicantGranbio, Inc.
Decision Date1994-04-20
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

UNKNOWN is the device name listed in this FDA 510(k) record. The listed applicant is Granbio, Inc.. It received FDA 510(k) clearance on 1994-04-20 under 510(k) number K934774. 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 UNKNOWN?

UNKNOWN is a medical device that received FDA 510(k) clearance on 1994-04-20. The listed applicant is Granbio, Inc.. The 510(k) number is K934774.

When did UNKNOWN receive FDA 510(k) clearance?

UNKNOWN received FDA 510(k) clearance on 1994-04-20, under 510(k) number K934774.

Who is the listed applicant for UNKNOWN?

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 UNKNOWN?

The FDA product code for UNKNOWN is LSE.

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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.

K951822EBNA ENZYME IMMUNOASSAY KITK901156EIA 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: LSE)

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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.K062211BIOPLEX 2200 EBV IGG PANEL FOR 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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