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FDA 510(k)

BACTIRACIN DIAGNOSTIC DISC

K-Number: K802497 · 1980-11-12

ApplicantOxoid U.S.A., Inc.
Decision Date1980-11-12
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTIRACIN DIAGNOSTIC DISC is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid U.S.A., Inc.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802497. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTIRACIN DIAGNOSTIC DISC?

BACTIRACIN DIAGNOSTIC DISC is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Oxoid U.S.A., Inc.. The 510(k) number is K802497.

When did BACTIRACIN DIAGNOSTIC DISC receive FDA 510(k) clearance?

BACTIRACIN DIAGNOSTIC DISC received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802497.

Who is the listed applicant for BACTIRACIN DIAGNOSTIC DISC?

The FDA 510(k) record lists Oxoid U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BACTIRACIN DIAGNOSTIC DISC?

The FDA product code for BACTIRACIN DIAGNOSTIC DISC is JTO.

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Other records listing Oxoid U.S.A., Inc. as applicant

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Related Devices (Code: JTO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, Inc.

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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