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FDA 510(k)

DISP. HYDROGEN & CO2 GENERATOR ENVELOPE

K-Number: K800539 · 1980-04-08

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1980-04-08
Product CodeKZJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DISP. HYDROGEN & CO2 GENERATOR ENVELOPE is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1980-04-08 under 510(k) number K800539. 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 DISP. HYDROGEN & CO2 GENERATOR ENVELOPE?

DISP. HYDROGEN & CO2 GENERATOR ENVELOPE is a medical device that received FDA 510(k) clearance on 1980-04-08. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K800539.

When did DISP. HYDROGEN & CO2 GENERATOR ENVELOPE receive FDA 510(k) clearance?

DISP. HYDROGEN & CO2 GENERATOR ENVELOPE received FDA 510(k) clearance on 1980-04-08, under 510(k) number K800539.

Who is the listed applicant for DISP. HYDROGEN & CO2 GENERATOR ENVELOPE?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISP. HYDROGEN & CO2 GENERATOR ENVELOPE?

The FDA product code for DISP. HYDROGEN & CO2 GENERATOR ENVELOPE is KZJ.

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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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