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FDA 510(k)

ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT

K-Number: K884026 · 1989-02-03

ApplicantOxoid U.S.A., Inc.
Decision Date1989-02-03
Product CodeGNA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT 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 1989-02-03 under 510(k) number K884026. The device is classified under product code GNA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT?

ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT is a medical device that received FDA 510(k) clearance on 1989-02-03. The listed applicant is Oxoid U.S.A., Inc.. The 510(k) number is K884026.

When did ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT receive FDA 510(k) clearance?

ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT received FDA 510(k) clearance on 1989-02-03, under 510(k) number K884026.

Who is the listed applicant for ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT?

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 ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT?

The FDA product code for ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT is GNA.

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

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.

K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMK884208LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)K874303STAPHYLASE TESTK872956SORBITOL MACCONKEY AGAR NO. 3 CM 813K872135MCBRIDE MEDIUM CM 819K870945RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122

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Related Devices (Code: GNA)

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.

K071799MODIFICATION TO BIOSTAR OIA SHIGATOXIverness Medical Professional DiagnosticsK031367DUOPATH VEROTOXINS GLISA TESTEmd Chemicals, Inc.K993401DRYSPOT E.COLI 0157 KITOxoid , Ltd.K981734VTEC-RPLA SEIKENDenka Seiken'SK962028WELLCOLEX E-COLI OI57 ZC60Murex Diagnostics, Inc.K953362PREMIER EHECMeridian Diagnostics, 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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