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FDA 510(k)

ETEST FOSFOMYCIN

K-Number: K981136 · 1998-06-09

ApplicantAb Biodisk
Decision Date1998-06-09
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST FOSFOMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 1998-06-09 under 510(k) number K981136. 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 FOSFOMYCIN?

ETEST FOSFOMYCIN is a medical device that received FDA 510(k) clearance on 1998-06-09. The listed applicant is Ab Biodisk. The 510(k) number is K981136.

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

ETEST FOSFOMYCIN received FDA 510(k) clearance on 1998-06-09, under 510(k) number K981136.

Who is the listed applicant for ETEST FOSFOMYCIN?

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 FOSFOMYCIN?

The FDA product code for ETEST FOSFOMYCIN 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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