Wondfo Phencyclidine Urine Test, Tricyclic Antidepressants Urine Test
FDA 510(k) K112395 · Guangzhou Wondfo Biotech Co., Ltd.
510(k) numberK112395
Submission
- Device name
- Wondfo Phencyclidine Urine Test, Tricyclic Antidepressants Urine Test
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
Gaithersburg, MD, US - Received
- August 19, 2011
- Decision date
- September 9, 2011
- 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 Wondfo Phencyclidine Urine Test, Tricyclic Antidepressants Urine Test cleared by the FDA?
Wondfo Phencyclidine Urine Test, Tricyclic Antidepressants Urine Test (K112395) received a 510(k) decision of Substantially Equivalent on September 9, 2011, 21 days after the submission was received.
What is the product code of K112395?
The FDA product code is LFG – Radioimmunoassay, Tricyclic Antidepressant Drugs, a Class II (moderate risk) device regulated under 21 CFR 862.3910.