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FDA 510(k)

ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE

K-Number: K021445 · 2002-06-06

ApplicantAb Biodisk
Decision Date2002-06-06
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 2002-06-06 under 510(k) number K021445. 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 CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE?

ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE is a medical device that received FDA 510(k) clearance on 2002-06-06. The listed applicant is Ab Biodisk. The 510(k) number is K021445.

When did ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE receive FDA 510(k) clearance?

ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE received FDA 510(k) clearance on 2002-06-06, under 510(k) number K021445.

Who is the listed applicant for ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE?

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 CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE?

The FDA product code for ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE 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 TESTINGK020748ETEST ERTAPENEM

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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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