AUTOFLUOR V
FDA 510(k) clearance K861978 · decided 1986-06-10
Clearance details
- K-number
- K861978
- Device name
- AUTOFLUOR V
- Applicant
- Technia Diagnostics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1986-05-21
- Decision date
- 1986-06-10
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- KTL
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Elwood, KS, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Technia 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.