TRUQUANT BR RIA
FDA 510(k) clearance K965141 · decided 1997-10-31
Clearance details
- K-number
- K965141
- Device name
- TRUQUANT BR RIA
- Applicant
- Biomira USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-23
- Decision date
- 1997-10-31
- Days to decision
- 312 days
- Clearance type
- Traditional
- Product code
- MOI
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Cranberry, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biomira USA
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.