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FDA 510(k)

GAS GENERATING KIT, CO2

K-Number: K820010 · 1982-01-28

ApplicantOxoid U.S.A., Inc.
Decision Date1982-01-28
Product CodeKZJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GAS GENERATING KIT, CO2 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 1982-01-28 under 510(k) number K820010. The device is classified under product code KZJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAS GENERATING KIT, CO2?

GAS GENERATING KIT, CO2 is a medical device that received FDA 510(k) clearance on 1982-01-28. The listed applicant is Oxoid U.S.A., Inc.. The 510(k) number is K820010.

When did GAS GENERATING KIT, CO2 receive FDA 510(k) clearance?

GAS GENERATING KIT, CO2 received FDA 510(k) clearance on 1982-01-28, under 510(k) number K820010.

Who is the listed applicant for GAS GENERATING KIT, CO2?

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 GAS GENERATING KIT, CO2?

The FDA product code for GAS GENERATING KIT, CO2 is KZJ.

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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 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: KZJ)

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.

K881502BREWER GEL FOR CAMPYLOBACTERFairleigh Dickinson Laboratories, Inc.K875362BREWER GEL FOR ANAEROBESFairleigh Dickinson Laboratories, Inc.K872782BBL(R) GASPAK CO2 POUCH(TM)Bd Becton Dickinson Vacutainer Systems PreanalyticK871709ANAEROBIC TRANSPORT POUCH (CATALYST-FREE)Difco Laboratories, Inc.K871238ANABAGScott Laboratories, Inc.K862123BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICEMarion Laboratories, 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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