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FDA 510(k)

ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS

K-Number: K945433 · 1995-03-17

ApplicantAb Biodisk
Decision Date1995-03-17
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 1995-03-17 under 510(k) number K945433. 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/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS?

ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS is a medical device that received FDA 510(k) clearance on 1995-03-17. The listed applicant is Ab Biodisk. The 510(k) number is K945433.

When did ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS receive FDA 510(k) clearance?

ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS received FDA 510(k) clearance on 1995-03-17, under 510(k) number K945433.

Who is the listed applicant for ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS?

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/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS?

The FDA product code for ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS 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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