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FDA 510(k)

OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS

K-Number: K860153 · 1986-03-04

ApplicantOxoid U.S.A., Inc.
Decision Date1986-03-04
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS 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 1986-03-04 under 510(k) number K860153. 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 OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS?

OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS is a medical device that received FDA 510(k) clearance on 1986-03-04. The listed applicant is Oxoid U.S.A., Inc.. The 510(k) number is K860153.

When did OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS receive FDA 510(k) clearance?

OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS received FDA 510(k) clearance on 1986-03-04, under 510(k) number K860153.

Who is the listed applicant for OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS?

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 OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS?

The FDA product code for OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS is JTN.

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

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K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMK884026ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KITK884208LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)K874303STAPHYLASE TESTK872956SORBITOL MACCONKEY AGAR NO. 3 CM 813K872135MCBRIDE MEDIUM CM 819

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Related Devices (Code: JTN)

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.

K262113HardyDisk AST Tebipenem 10µg (TBP10)Hardy DiagnosticsK261781Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60Thermo Fisher Scientific (Oxoid Ltd.)K261853Gepotidacin GEP 10 µgLiofilchem, Inc.K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy DiagnosticsK251337Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10Thermo Fisher Scientific (Oxoid Ltd.)K253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy Diagnostics

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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