Device, Gas Generating
FDA product code KZJ · Class I (low risk) · 21 CFR 866.2580 · Microbiology
18510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881502 | Brewer Gel for CampylobacterKZJ · Traditional | Fairleigh Dickinson Laboratories, Inc. | 04/27/1988SE |
| K875362 | Brewer Gel for AnaerobesKZJ · Traditional | Fairleigh Dickinson Laboratories, Inc. | 01/27/1988SE |
| K872782 | Bbl(R) Gaspak CO2 Pouch(Tm)KZJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/06/1987SE |
| K871709 | Anaerobic Transport Pouch (Catalyst-Free)KZJ · Traditional | Difco Laboratories, Inc. | 05/15/1987SE |
| K871238 | AnabagKZJ · Traditional | Scott Laboratories, Inc. | 04/03/1987SE |
| K862123 | Biosphere Anaerobic Environmental DeviceKZJ · Traditional | Marion Laboratories, Inc. | 06/16/1986SE |
| K853534 | BBL Campy PouchKZJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/29/1985SE |
| K845008 | Bio-Bag Environmental Chamber -Type A-Multi-PlateKZJ · Traditional | Marion Laboratories, Inc. | 03/05/1985SE |
| K844571 | Campypak Plus W/Palladium Catalyst Dispos. HydrogeKZJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/30/1985SE |
| K841117 | Gaspak Plus Dispos. Hydrogen &KZJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/04/1984SE |
| K832229 | BBL Anagel PowderKZJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/12/1983SE |
| K820308 | Ana-Disc SystemKZJ · Traditional | Flow Laboratories, Inc. | 03/04/1982SE |
| K820010 | Gas Generating Kit, CO2KZJ · Traditional | Oxoid U.S.A., Inc. | 01/28/1982SE |
| K811957 | CampypakKZJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/23/1981SE |
| K802494 | Gas Generating Kit System for Campylob.KZJ · Traditional | Oxoid U.S.A., Inc. | 11/12/1980SE |
| K800899 | Lab-Tek Anacult Anaerobic Culture ChambeKZJ · Traditional | Miles Laboratories, Inc. | 05/23/1980SE |
| K800796 | Gas Pak II Dis. Generator EnvelopesKZJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/24/1980SE |
| K800539 | Disp. Hydrogen & CO2 Generator EnvelopeKZJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/08/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1983-2026 Class II | BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic useBD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating… | Becton Dickinson & Co. | 04/07/2026Open, Classified |
| Z-1982-2026 Class II | BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic useBD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating… | Becton Dickinson & Co. | 04/07/2026Open, Classified |
| Z-0480-2011 | GasPak EZ Large Incubation Container, a component of the GasPak EZ Gas Generating…In vitro diagnostic reagent containers may be defective and could cause incorrect test results in patient… | Becton Dickinson & Co. | 08/13/2010Terminated |