KZJ · Device, Gas Generating
Microbiology · 21 CFR 866.2580 · Class 1
Overview
| Product Code | KZJ |
|---|---|
| Device Name | Device, Gas Generating |
| Regulation | 21 CFR 866.2580 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
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 | BREWER GEL FOR CAMPYLOBACTER | Fairleigh Dickinson Laboratories, Inc. | Apr 27, 1988 | SESE |
| K875362 | BREWER GEL FOR ANAEROBES | Fairleigh Dickinson Laboratories, Inc. | Jan 27, 1988 | SESE |
| K872782 | BBL(R) GASPAK CO2 POUCH(TM) | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 6, 1987 | SESE |
| K871709 | ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) | Difco Laboratories, Inc. | May 15, 1987 | SESE |
| K871238 | ANABAG | Scott Laboratories, Inc. | Apr 3, 1987 | SESE |
| K862123 | BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE | Marion Laboratories, Inc. | Jun 16, 1986 | SESE |
| K853534 | BBL CAMPY POUCH | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 29, 1985 | SESE |
| K845008 | BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE | Marion Laboratories, Inc. | Mar 5, 1985 | SESE |
| K844571 | CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jan 30, 1985 | SESE |
| K841117 | GASPAK PLUS DISPOS. HYDROGEN & | Bd Becton Dickinson Vacutainer Systems Preanalytic | Apr 4, 1984 | SESE |
| K832229 | BBL ANAGEL POWDER | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 12, 1983 | SESE |
| K820308 | ANA-DISC SYSTEM | Flow Laboratories, Inc. | Mar 4, 1982 | SESE |
| K820010 | GAS GENERATING KIT, CO2 | Oxoid U.S.A., Inc. | Jan 28, 1982 | SESE |
| K811957 | CAMPYPAK | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jul 23, 1981 | SESE |
| K802494 | GAS GENERATING KIT SYSTEM FOR CAMPYLOB. | Oxoid U.S.A., Inc. | Nov 12, 1980 | SESE |
| K800899 | LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE | Miles Laboratories, Inc. | May 23, 1980 | SESE |
| K800796 | GAS PAK II DIS. GENERATOR ENVELOPES | Bd Becton Dickinson Vacutainer Systems Preanalytic | Apr 24, 1980 | SESE |
| K800539 | 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
