GAS GENERATING KIT SYSTEM FOR CAMPYLOB.
FDA 510(k) clearance K802494 · decided 1980-11-12
Clearance details
- K-number
- K802494
- Device name
- GAS GENERATING KIT SYSTEM FOR CAMPYLOB.
- Applicant
- Oxoid U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-10-10
- Decision date
- 1980-11-12
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- KZJ
- Device class
- 1
- Regulation number
- 866.2580
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
Recalls involving this device
No recalls on record reference this clearance.