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FDA 510(k)

DEFAZOLIN 30MCG. SENSITIVITY DISCS

K-Number: K832910 · 1983-11-14

ApplicantDifco Laboratories, Inc.
Decision Date1983-11-14
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DEFAZOLIN 30MCG. SENSITIVITY DISCS 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 1983-11-14 under 510(k) number K832910. 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 DEFAZOLIN 30MCG. SENSITIVITY DISCS?

DEFAZOLIN 30MCG. SENSITIVITY DISCS is a medical device that received FDA 510(k) clearance on 1983-11-14. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K832910.

When did DEFAZOLIN 30MCG. SENSITIVITY DISCS receive FDA 510(k) clearance?

DEFAZOLIN 30MCG. SENSITIVITY DISCS received FDA 510(k) clearance on 1983-11-14, under 510(k) number K832910.

Who is the listed applicant for DEFAZOLIN 30MCG. SENSITIVITY DISCS?

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 DEFAZOLIN 30MCG. SENSITIVITY DISCS?

The FDA product code for DEFAZOLIN 30MCG. SENSITIVITY DISCS is JTN.

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Other records listing Difco Laboratories, Inc. 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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