EMIT DESIPRAMINE ASSAY
FDA 510(k) clearance K861155 · decided 1986-05-02
Clearance details
- K-number
- K861155
- Device name
- EMIT DESIPRAMINE ASSAY
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1986-03-28
- Decision date
- 1986-05-02
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- LFG
- Device class
- 2
- Regulation number
- 862.3910
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Syva Co.
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.