Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart C — Microbiology Devices](/submissions/MI/subpart-c%E2%80%94microbiology-devices) → [21 CFR 866.2580](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2580) → KZJ — Device, Gas Generating # KZJ · Device, Gas Generating _Microbiology · 21 CFR 866.2580 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ ## Overview - **Product Code:** KZJ - **Device Name:** Device, Gas Generating - **Regulation:** [21 CFR 866.2580](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2580) - **Device Class:** 1 - **Review Panel:** [Microbiology](/submissions/MI) ## Identification A gas-generating device is a device intended for medical purposes that produces predetermined amounts of selected gases to be used in a closed chamber in order to establish suitable atmospheric conditions for cultivation of microorganisms with special atmospheric requirements. The device aids in the diagnosis of disease. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. ## Recent Cleared Devices (18 of 18) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K881502](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K881502.md) | BREWER GEL FOR CAMPYLOBACTER | Fairleigh Dickinson Laboratories, Inc. | Apr 27, 1988 | SESE | | [K875362](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K875362.md) | BREWER GEL FOR ANAEROBES | Fairleigh Dickinson Laboratories, Inc. | Jan 27, 1988 | SESE | | [K872782](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K872782.md) | BBL(R) GASPAK CO2 POUCH(TM) | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 6, 1987 | SESE | | [K871709](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K871709.md) | ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) | Difco Laboratories, Inc. | May 15, 1987 | SESE | | [K871238](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K871238.md) | ANABAG | Scott Laboratories, Inc. | Apr 3, 1987 | SESE | | [K862123](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K862123.md) | BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE | Marion Laboratories, Inc. | Jun 16, 1986 | SESE | | [K853534](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K853534.md) | BBL CAMPY POUCH | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 29, 1985 | SESE | | [K845008](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K845008.md) | BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE | Marion Laboratories, Inc. | Mar 5, 1985 | SESE | | [K844571](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K844571.md) | CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jan 30, 1985 | SESE | | [K841117](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K841117.md) | GASPAK PLUS DISPOS. HYDROGEN & | Bd Becton Dickinson Vacutainer Systems Preanalytic | Apr 4, 1984 | SESE | | [K832229](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K832229.md) | BBL ANAGEL POWDER | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 12, 1983 | SESE | | [K820308](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K820308.md) | ANA-DISC SYSTEM | Flow Laboratories, Inc. | Mar 4, 1982 | SESE | | [K820010](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K820010.md) | GAS GENERATING KIT, CO2 | Oxoid U.S.A., Inc. | Jan 28, 1982 | SESE | | [K811957](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K811957.md) | CAMPYPAK | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jul 23, 1981 | SESE | | [K802494](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K802494.md) | GAS GENERATING KIT SYSTEM FOR CAMPYLOB. | Oxoid U.S.A., Inc. | Nov 12, 1980 | SESE | | [K800899](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K800899.md) | LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE | Miles Laboratories, Inc. | May 23, 1980 | SESE | | [K800796](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K800796.md) | GAS PAK II DIS. GENERATOR ENVELOPES | Bd Becton Dickinson Vacutainer Systems Preanalytic | Apr 24, 1980 | SESE | | [K800539](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K800539.md) | DISP. HYDROGEN & CO2 GENERATOR ENVELOPE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Apr 8, 1980 | SESE | ## Top Applicants - Bd Becton Dickinson Vacutainer Systems Preanalytic — 8 clearances - Fairleigh Dickinson Laboratories, Inc. — 2 clearances - Marion Laboratories, Inc. — 2 clearances - Oxoid U.S.A., Inc. — 2 clearances - Difco Laboratories, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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