RANDOX DIGOXIN
FDA 510(k) clearance K011302 · decided 2001-07-02
Clearance details
- K-number
- K011302
- Device name
- RANDOX DIGOXIN
- Applicant
- Randox Laboratories, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-30
- Decision date
- 2001-07-02
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- KXT
- Device class
- 2
- Regulation number
- 862.3320
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Crumlin, Co. Antrim, IE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Randox Laboratories
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.
Recalls involving this device
No recalls on record reference this clearance.