LEGIONELLA DIFFERENTIATION DISK
FDA 510(k) clearance K834067 · decided 1984-01-03
Clearance details
- K-number
- K834067
- Device name
- LEGIONELLA DIFFERENTIATION DISK
- Applicant
- Remel Co.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-25
- Decision date
- 1984-01-03
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- GRO
- Device class
- 2
- Regulation number
- 866.3300
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Remel Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LEGIONELLA CULTURE CONFIRMATIN KIT (K851271) | Gen-Probe, Inc. | 1985-07-08 |
| PHADEBACT HAEMOPHILUS TEST (K802423) | Pharmacia, Inc. | 1980-11-12 |
| BACTOGEN-H. INFLUENZAE TYPE B (K800493) | Armkel, LLC | 1980-04-04 |
Recalls involving this device
No recalls on record reference this clearance.