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FDA 510(k)

CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K-Number: K964495 · 1997-02-07

ApplicantUnipath , Ltd.
Decision Date1997-02-07
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY 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 1997-02-07 under 510(k) number K964495. 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 CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC?

CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC is a medical device that received FDA 510(k) clearance on 1997-02-07. The listed applicant is Unipath , Ltd.. The 510(k) number is K964495.

When did CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC receive FDA 510(k) clearance?

CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC received FDA 510(k) clearance on 1997-02-07, under 510(k) number K964495.

Who is the listed applicant for CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY 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 CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC?

The FDA product code for CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY 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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