Agilon Strip
FDA 510(k) clearance K193487 · decided 2020-03-30
Clearance details
- K-number
- K193487
- Device name
- Agilon Strip
- Applicant
- Biogennix, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-12-17
- Decision date
- 2020-03-30
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biogennix
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.