Emit Desipramine Assay
FDA 510(k) K861155 · Syva Co.
510(k) numberK861155
Submission
- Device name
- Emit Desipramine Assay
- Applicant
- Syva Co.
Palo Alto, CA, US - Received
- March 28, 1986
- Decision date
- May 2, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LFG – Radioimmunoassay, Tricyclic Antidepressant Drugs
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3910
- Specialty
- Clinical Toxicology
Intended to measure any of the tricyclic antidepressant drugs in serum or urine.
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Questions and answers
When was Emit Desipramine Assay cleared by the FDA?
Emit Desipramine Assay (K861155) received a 510(k) decision of Substantially Equivalent on May 2, 1986, 35 days after the submission was received.
What is the product code of K861155?
The FDA product code is LFG – Radioimmunoassay, Tricyclic Antidepressant Drugs, a Class II (moderate risk) device regulated under 21 CFR 862.3910.