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FDA 510(k)

CEFIXIME 5 MCG SENSITIVITY DISKS

K-Number: K894829 · 1989-09-08

ApplicantDifco Laboratories, Inc.
Decision Date1989-09-08
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CEFIXIME 5 MCG SENSITIVITY DISKS is the device name listed in this FDA 510(k) record. The listed applicant is Difco Laboratories, Inc.. It received FDA 510(k) clearance on 1989-09-08 under 510(k) number K894829. 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 SENSITIVITY DISKS?

CEFIXIME 5 MCG SENSITIVITY DISKS is a medical device that received FDA 510(k) clearance on 1989-09-08. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K894829.

When did CEFIXIME 5 MCG SENSITIVITY DISKS receive FDA 510(k) clearance?

CEFIXIME 5 MCG SENSITIVITY DISKS received FDA 510(k) clearance on 1989-09-08, under 510(k) number K894829.

Who is the listed applicant for CEFIXIME 5 MCG SENSITIVITY DISKS?

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

What is the FDA product code for CEFIXIME 5 MCG SENSITIVITY DISKS?

The FDA product code for CEFIXIME 5 MCG SENSITIVITY DISKS 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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