UNILET LANCET
FDA 510(k) clearance K842517 · decided 1984-09-20
Clearance details
- K-number
- K842517
- Device name
- UNILET LANCET
- Applicant
- Ulster Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-10
- Decision date
- 1984-09-20
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- FML
- Device class
- 1
- Regulation number
- 880.6140
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ulster Scientific
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 |
|---|---|---|
| GLOVES, FLOOR (K780181) | Tillotson Rubber Co., Inc. | 1978-02-21 |
Recalls involving this device
No recalls on record reference this clearance.