Acon Tca One Step Tricyclic Antidepressant Test Strip and Device
FDA 510(k) K021526 · ACON Laboratories, Inc.
510(k) numberK021526
Submission
- Device name
- Acon Tca One Step Tricyclic Antidepressant Test Strip and Device
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- May 10, 2002
- Decision date
- July 17, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Acon Tca One Step Tricyclic Antidepressant Test Strip and Device cleared by the FDA?
Acon Tca One Step Tricyclic Antidepressant Test Strip and Device (K021526) received a 510(k) decision of Substantially Equivalent on July 17, 2002, 68 days after the submission was received.
What is the product code of K021526?
The FDA product code is LFG – Radioimmunoassay, Tricyclic Antidepressant Drugs, a Class II (moderate risk) device regulated under 21 CFR 862.3910.