ANA-DISC SYSTEM
FDA 510(k) clearance K820308 · decided 1982-03-04
Clearance details
- K-number
- K820308
- Device name
- ANA-DISC SYSTEM
- Applicant
- Flow Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-02-04
- Decision date
- 1982-03-04
- Days to decision
- 28 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 |
| GAS GENERATING KIT, CO2 (K820010) | Oxoid U.S.A., Inc. | 1982-01-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 3M BRAND MICROBIAL PROFILE SYSTEM (N50538/S001) | Flow Laboratories, Inc. | 1981-04-17 |
| FLOW MIC SYSTEM (N50538) | Flow Laboratories, Inc. | 1980-07-15 |