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FDA 510(k)

ETEST FOR LEVOFLOXACIN

K-Number: K971697 · 1997-07-14

ApplicantAb Biodisk
Decision Date1997-07-14
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST FOR LEVOFLOXACIN is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 1997-07-14 under 510(k) number K971697. 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 LEVOFLOXACIN?

ETEST FOR LEVOFLOXACIN is a medical device that received FDA 510(k) clearance on 1997-07-14. The listed applicant is Ab Biodisk. The 510(k) number is K971697.

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

ETEST FOR LEVOFLOXACIN received FDA 510(k) clearance on 1997-07-14, under 510(k) number K971697.

Who is the listed applicant for ETEST FOR LEVOFLOXACIN?

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 LEVOFLOXACIN?

The FDA product code for ETEST FOR LEVOFLOXACIN 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 BACTERIAK042392DAPTOMYCINK042390ETEST FOR GEMIFLOXACINK040560ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTINGK021445ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE

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Related Devices (Code: JWY)

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.

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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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