Direct LDL Cholesterol (LDL)
FDA 510(k) clearance K161691 · decided 2017-03-20
Clearance details
- K-number
- K161691
- Device name
- Direct LDL Cholesterol (LDL)
- Applicant
- Randox Laboratories Limited
- Decision
- Substantially Equivalent
- Date received
- 2016-06-20
- Decision date
- 2017-03-20
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- MRR
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Crumlin, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Randox Laboratories Limited
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.