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FDA 510(k)

ETEST FOR QUINUPRISTIN/DALFOPRISTIN

K-Number: K992993 · 1999-11-16

ApplicantAb Biodisk
Decision Date1999-11-16
Product CodeLTX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST FOR QUINUPRISTIN/DALFOPRISTIN is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 1999-11-16 under 510(k) number K992993. 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 FOR QUINUPRISTIN/DALFOPRISTIN?

ETEST FOR QUINUPRISTIN/DALFOPRISTIN is a medical device that received FDA 510(k) clearance on 1999-11-16. The listed applicant is Ab Biodisk. The 510(k) number is K992993.

When did ETEST FOR QUINUPRISTIN/DALFOPRISTIN receive FDA 510(k) clearance?

ETEST FOR QUINUPRISTIN/DALFOPRISTIN received FDA 510(k) clearance on 1999-11-16, under 510(k) number K992993.

Who is the listed applicant for ETEST FOR QUINUPRISTIN/DALFOPRISTIN?

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 FOR QUINUPRISTIN/DALFOPRISTIN?

The FDA product code for ETEST FOR QUINUPRISTIN/DALFOPRISTIN 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

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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.

K002139ETEST LINEZOLIDAb 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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