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FDA 510(k)

REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK

K-Number: K925060 · 1992-12-03

ApplicantRemel Co.
Decision Date1992-12-03
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1992-12-03 under 510(k) number K925060. 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 REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK?

REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK is a medical device that received FDA 510(k) clearance on 1992-12-03. The listed applicant is Remel Co.. The 510(k) number is K925060.

When did REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK receive FDA 510(k) clearance?

REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK received FDA 510(k) clearance on 1992-12-03, under 510(k) number K925060.

Who is the listed applicant for REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK?

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

What is the FDA product code for REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK?

The FDA product code for REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK is JTN.

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Other records listing Remel Co. as applicant

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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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