ANA TEST KIT
FDA 510(k) clearance K864668 · decided 1987-03-12
Clearance details
- K-number
- K864668
- Device name
- ANA TEST KIT
- Applicant
- Val Tech Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-02
- Decision date
- 1987-03-12
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- LKJ
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Val Tech Diagnostics
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.