KZJ
18 FDA 510(k) clearances · Product code
23 daysmedian time to decision
68 days90th percentile
18clearances measured
FDA profile
- Official device name
- Device, Gas Generating
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2580
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 1995: 1 · 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BREWER GEL FOR CAMPYLOBACTER (K881502) | Fairleigh Dickinson Laboratories, Inc. | 1988-04-27 |
| BREWER GEL FOR ANAEROBES (K875362) | Fairleigh Dickinson Laboratories, Inc. | 1988-01-27 |
| BBL(R) GASPAK CO2 POUCH(TM) (K872782) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-08-06 |
| ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) (K871709) | Difco Laboratories, Inc. | 1987-05-15 |
| ANABAG (K871238) | Scott Laboratories, Inc. | 1987-04-03 |
| BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE (K862123) | Marion Laboratories, Inc. | 1986-06-16 |
| BBL CAMPY POUCH (K853534) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-08-29 |
| BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE (K845008) | Marion Laboratories, Inc. | 1985-03-05 |
| CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE (K844571) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-30 |
| GASPAK PLUS DISPOS. HYDROGEN & (K841117) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-04-04 |
| BBL ANAGEL POWDER (K832229) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-08-12 |
| ANA-DISC SYSTEM (K820308) | Flow Laboratories, Inc. | 1982-03-04 |
| GAS GENERATING KIT, CO2 (K820010) | Oxoid U.S.A., Inc. | 1982-01-28 |
| CAMPYPAK (K811957) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-07-23 |
| GAS GENERATING KIT SYSTEM FOR CAMPYLOB. (K802494) | Oxoid U.S.A., Inc. | 1980-11-12 |
| LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE (K800899) | Miles Laboratories, Inc. | 1980-05-23 |
| GAS PAK II DIS. GENERATOR ENVELOPES (K800796) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-04-24 |
| DISP. HYDROGEN & CO2 GENERATOR ENVELOPE (K800539) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-04-08 |
Track KZJ automatically
Every clearance here is in the API, with alerts when new ones post.