Product code KZJ
- Device name
- Device, Gas Generating
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2580
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K881502 | BREWER GEL FOR CAMPYLOBACTER | Fairleigh Dickinson Laboratories, Inc. | 1988-04-27 |
| K875362 | BREWER GEL FOR ANAEROBES | Fairleigh Dickinson Laboratories, Inc. | 1988-01-27 |
| K872782 | BBL(R) GASPAK CO2 POUCH(TM) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-08-06 |
| K871709 | ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) | Difco Laboratories, Inc. | 1987-05-15 |
| K871238 | ANABAG | Scott Laboratories, Inc. | 1987-04-03 |
| K862123 | BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE | Marion Laboratories, Inc. | 1986-06-16 |
| K853534 | BBL CAMPY POUCH | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-08-29 |
| K845008 | BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE | Marion Laboratories, Inc. | 1985-03-05 |
| K844571 | CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-30 |
| K841117 | GASPAK PLUS DISPOS. HYDROGEN & | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-04-04 |
| K832229 | BBL ANAGEL POWDER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-08-12 |
| K820308 | ANA-DISC SYSTEM | Flow Laboratories, Inc. | 1982-03-04 |
| K820010 | GAS GENERATING KIT, CO2 | Oxoid U.S.A., Inc. | 1982-01-28 |
| K811957 | CAMPYPAK | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-07-23 |
| K802494 | GAS GENERATING KIT SYSTEM FOR CAMPYLOB. | Oxoid U.S.A., Inc. | 1980-11-12 |
| K800899 | LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE | Miles Laboratories, Inc. | 1980-05-23 |
| K800796 | GAS PAK II DIS. GENERATOR ENVELOPES | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-04-24 |
| K800539 | DISP. HYDROGEN & CO2 GENERATOR ENVELOPE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-04-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00382902604679 | BD BBL ™ GasPak™ 100 Vented Lid | BECTON, DICKINSON AND COMPANY | 2024-08-29 |
| 00673693228527 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 05032384029648 | ANAEROBIC CATALYST | OXOID LIMITED | 2022-12-12 |
| 05032384446148 | ANAEROGEN COMPACT | OXOID LIMITED | 2022-12-12 |
| 05032384028665 | ANAEROGEN 2.5L 10 PACK | OXOID LIMITED | 2022-12-08 |
| 05032384028672 | ANAEROGEN 3.5L 10 PACK | OXOID LIMITED | 2022-12-08 |
| 05032384028870 | CAMPYGEN (2.5 LITRES) | OXOID LIMITED | 2022-12-08 |
| 05032384028887 | CAMPYGEN (3.5 LITRES) | OXOID LIMITED | 2022-12-08 |
| 05032384029921 | ANAEROGEN COMPACT 10 PACK | OXOID LIMITED | 2022-12-08 |
| 05032384034611 | CAMPYGEN COMPACT (20 PER PACK) | OXOID LIMITED | 2022-12-08 |
| 05032384034932 | CO2GEN (10 SACHETS PER PACK) | OXOID LIMITED | 2022-12-08 |
| 05032384069132 | ANAEROGEN COMPACT 20 PACK | OXOID LIMITED | 2022-12-08 |
| 05032384123261 | CO2GEN COMPACT (20 PER PACK) | OXOID LIMITED | 2022-12-08 |
| 05032384161935 | ANAEROGEN W-ZIP COMPACT | OXOID LIMITED | 2022-12-08 |
| 05032384003761 | YERSINIA SELECTIVE AGAR BASE | OXOID LIMITED | 2022-12-08 |
| 05032384028405 | SINGLE DISC EJECTORS | OXOID LIMITED | 2022-12-07 |
| 05032384060122 | DESICCATED CARTRIDGE CONTAINER | OXOID LIMITED | 2022-12-07 |
| 00816068020900 | Advanced Instruments Anoxomat III Anaerobic Culture System (100V - 120V) | Advanced Instruments, LLC | 2020-09-21 |
| 00816068020917 | Advanced Instruments Ergonomic Culture Jar, Small | Advanced Instruments, LLC | 2020-09-21 |
| 00816068020924 | Advanced Instruments Ergonomic Culture Jar, Large | Advanced Instruments, LLC | 2020-09-21 |
| 00816068020948 | Advanced Instruments Standard Anoxomat Jar, Medium | Advanced Instruments, LLC | 2020-09-21 |
| 00816068020955 | Advanced Instruments Standard Anoxomat Jar, Large | Advanced Instruments, LLC | 2020-09-21 |
| 00816068020962 | Advanced Instruments Palladox Disposable Satchet | Advanced Instruments, LLC | 2020-09-21 |
| 30382902600016 | BD GasPak™ EZ Anaerobe Container System Sachets with Indicator | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 30382902606780 | BD GasPak™ EZ Anaerobe Container System Sachets | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 30382902606797 | BD GasPak™ EZ CO2 Container System Sachets | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 30382902606803 | BD GasPak™ EZ Campy Container System Sachets | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 30382902606834 | BD GasPak™ EZ Anaerobe Gas Generating Pouch System with Indicator | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 30382902606841 | BD GasPak™ EZ CO2 Gas Generating Pouch System | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 30382902606858 | BD GasPak™ EZ Campy Gas Generating Pouch System | BECTON, DICKINSON AND COMPANY | 2018-05-25 |