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FDA 510(k)

ETEST FOR GEMIFLOXACIN

K-Number: K042390 · 2004-11-19

ApplicantAb Biodisk
Decision Date2004-11-19
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST FOR GEMIFLOXACIN is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 2004-11-19 under 510(k) number K042390. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETEST FOR GEMIFLOXACIN?

ETEST FOR GEMIFLOXACIN is a medical device that received FDA 510(k) clearance on 2004-11-19. The listed applicant is Ab Biodisk. The 510(k) number is K042390.

When did ETEST FOR GEMIFLOXACIN receive FDA 510(k) clearance?

ETEST FOR GEMIFLOXACIN received FDA 510(k) clearance on 2004-11-19, under 510(k) number K042390.

Who is the listed applicant for ETEST FOR GEMIFLOXACIN?

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 GEMIFLOXACIN?

The FDA product code for ETEST FOR GEMIFLOXACIN is JWY.

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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 BACTERIAK042392DAPTOMYCINK040560ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTINGK021445ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAEK020748ETEST ERTAPENEM

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Related Devices (Code: JWY)

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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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