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FDA 510(k)

ETEST FOR CEFUROXIME

K-Number: K990722 · 1999-04-22

ApplicantAb Biodisk
Decision Date1999-04-22
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST FOR CEFUROXIME is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 1999-04-22 under 510(k) number K990722. 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 CEFUROXIME?

ETEST FOR CEFUROXIME is a medical device that received FDA 510(k) clearance on 1999-04-22. The listed applicant is Ab Biodisk. The 510(k) number is K990722.

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

ETEST FOR CEFUROXIME received FDA 510(k) clearance on 1999-04-22, under 510(k) number K990722.

Who is the listed applicant for ETEST FOR CEFUROXIME?

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 CEFUROXIME?

The FDA product code for ETEST FOR CEFUROXIME 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)

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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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