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FDA 510(k)

ETEST LINEZOLID

K-Number: K002139 · 2000-11-08

ApplicantAb Biodisk
Decision Date2000-11-08
Product CodeLTX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST LINEZOLID is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 2000-11-08 under 510(k) number K002139. The device is classified under product code LTX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETEST LINEZOLID?

ETEST LINEZOLID is a medical device that received FDA 510(k) clearance on 2000-11-08. The listed applicant is Ab Biodisk. The 510(k) number is K002139.

When did ETEST LINEZOLID receive FDA 510(k) clearance?

ETEST LINEZOLID received FDA 510(k) clearance on 2000-11-08, under 510(k) number K002139.

Who is the listed applicant for ETEST LINEZOLID?

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

What is the FDA product code for ETEST LINEZOLID?

The FDA product code for ETEST LINEZOLID is LTX.

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Other records listing Ab Biodisk 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.

K081325ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/MLK052366ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIAK042392DAPTOMYCINK042390ETEST FOR GEMIFLOXACINK040560ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTINGK021445ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE

View all 64 devices →

Related Devices (Code: LTX)

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.

K992993ETEST FOR QUINUPRISTIN/DALFOPRISTINAb Biodisk

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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