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FDA 510(k)

CEFIXIME 5 MCG SUSCEPTIBILITY DISK

K-Number: K900344 · 1990-02-05

ApplicantOrganon Teknika Corp.
Decision Date1990-02-05
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CEFIXIME 5 MCG SUSCEPTIBILITY DISK is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1990-02-05 under 510(k) number K900344. 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 5 MCG SUSCEPTIBILITY DISK?

CEFIXIME 5 MCG SUSCEPTIBILITY DISK is a medical device that received FDA 510(k) clearance on 1990-02-05. The listed applicant is Organon Teknika Corp.. The 510(k) number is K900344.

When did CEFIXIME 5 MCG SUSCEPTIBILITY DISK receive FDA 510(k) clearance?

CEFIXIME 5 MCG SUSCEPTIBILITY DISK received FDA 510(k) clearance on 1990-02-05, under 510(k) number K900344.

Who is the listed applicant for CEFIXIME 5 MCG SUSCEPTIBILITY DISK?

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

What is the FDA product code for CEFIXIME 5 MCG SUSCEPTIBILITY DISK?

The FDA product code for CEFIXIME 5 MCG SUSCEPTIBILITY DISK is JTN.

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Other records listing Organon Teknika Corp. as applicant

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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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