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FDA 510(k)

ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K-Number: K070262 · 2007-03-14

ApplicantOxoid , Ltd.
Decision Date2007-03-14
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid , Ltd.. It received FDA 510(k) clearance on 2007-03-14 under 510(k) number K070262. 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 ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC?

ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC is a medical device that received FDA 510(k) clearance on 2007-03-14. The listed applicant is Oxoid , Ltd.. The 510(k) number is K070262.

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

ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC received FDA 510(k) clearance on 2007-03-14, under 510(k) number K070262.

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

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

What is the FDA product code for ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC?

The FDA product code for ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC is JTN.

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Related Devices (Code: 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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