Device, Gas Generating
The Gas Generating Device is a laboratory instrument used in microbiology to create and maintain specific gaseous atmospheres, such as anaerobic or microaerophilic conditions, within specimen containers or culture chambers to support the growth of oxygen-sensitive microorganisms. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket submission required. The product code is KZJ, regulated under 21 CFR 866.2580, in the Microbiology medical specialty. No special flags apply to this device.
Research product code KZJ in seconds
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Basic Information
- Product Code
- KZJ
- Device Class
- FDA class 1
- Regulation Number
- 866.2580
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K881502 | BREWER GEL FOR CAMPYLOBACTER | Apr 27, 1988 | Substantially Equivalent | Fairleigh Dickinson Laboratories, Inc. |
| K875362 | BREWER GEL FOR ANAEROBES | Jan 27, 1988 | Substantially Equivalent | Fairleigh Dickinson Laboratories, Inc. |
| K872782 | BBL(R) GASPAK CO2 POUCH(TM) | Aug 06, 1987 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K871709 | ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) | May 15, 1987 | Substantially Equivalent | Difco Laboratories, Inc. |
| K871238 | ANABAG | Apr 03, 1987 | Substantially Equivalent | Scott Laboratories, Inc. |
| K862123 | BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE | Jun 16, 1986 | Substantially Equivalent | Marion Laboratories, Inc. |
| K853534 | BBL CAMPY POUCH | Aug 29, 1985 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K845008 | BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE | Mar 05, 1985 | Substantially Equivalent | Marion Laboratories, Inc. |
| K844571 | CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE | Jan 30, 1985 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K841117 | GASPAK PLUS DISPOS. HYDROGEN & | Apr 04, 1984 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K832229 | BBL ANAGEL POWDER | Aug 12, 1983 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K820308 | ANA-DISC SYSTEM | Mar 04, 1982 | Substantially Equivalent | Flow Laboratories, Inc. |
| K820010 | GAS GENERATING KIT, CO2 | Jan 28, 1982 | Substantially Equivalent | Oxoid U.S.A., Inc. |
| K811957 | CAMPYPAK | Jul 23, 1981 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K802494 | GAS GENERATING KIT SYSTEM FOR CAMPYLOB. | Nov 12, 1980 | Substantially Equivalent | Oxoid U.S.A., Inc. |
| K800899 | LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE | May 23, 1980 | Substantially Equivalent | Miles Laboratories, Inc. |
| K800796 | GAS PAK II DIS. GENERATOR ENVELOPES | Apr 24, 1980 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K800539 | DISP. HYDROGEN & CO2 GENERATOR ENVELOPE | Apr 08, 1980 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.