SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System
FDA 510(k) clearance K160282 · decided 2017-10-17
Clearance details
- K-number
- K160282
- Device name
- SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System
- Applicant
- Sd Biosensor
- Decision
- Substantially Equivalent
- Date received
- 2016-02-02
- Decision date
- 2017-10-17
- Days to decision
- 623 days
- Clearance type
- Traditional
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Suwon-Si, KR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sd Biosensor
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.