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FDA 510(k)

LORACARBEF 30MCG DISK

K-Number: K922791 · 1992-07-28

ApplicantDifco Laboratories, Inc.
Decision Date1992-07-28
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LORACARBEF 30MCG DISK 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 1992-07-28 under 510(k) number K922791. 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 LORACARBEF 30MCG DISK?

LORACARBEF 30MCG DISK is a medical device that received FDA 510(k) clearance on 1992-07-28. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K922791.

When did LORACARBEF 30MCG DISK receive FDA 510(k) clearance?

LORACARBEF 30MCG DISK received FDA 510(k) clearance on 1992-07-28, under 510(k) number K922791.

Who is the listed applicant for LORACARBEF 30MCG DISK?

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 LORACARBEF 30MCG DISK?

The FDA product code for LORACARBEF 30MCG DISK 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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