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FDA 510(k)

CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC

K-Number: K964496 · 1997-02-06

ApplicantUnipath , Ltd.
Decision Date1997-02-06
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 1997-02-06 under 510(k) number K964496. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC?

CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC is a medical device that received FDA 510(k) clearance on 1997-02-06. The listed applicant is Unipath , Ltd.. The 510(k) number is K964496.

When did CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC receive FDA 510(k) clearance?

CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC received FDA 510(k) clearance on 1997-02-06, under 510(k) number K964496.

Who is the listed applicant for CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC?

The FDA 510(k) record lists Unipath , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC?

The FDA product code for CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC is JTN.

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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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