PRESTIGE 24I; BIOLIS 24I; MGC 240
FDA 510(k) clearance K103531 · decided 2011-12-01
Clearance details
- K-number
- K103531
- Device name
- PRESTIGE 24I; BIOLIS 24I; MGC 240
- Applicant
- Tokyo Boeki Medisys, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-12-01
- Decision date
- 2011-12-01
- Days to decision
- 365 days
- Clearance type
- Traditional
- Product code
- CFR
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Tokyo Boeki Medisys
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.