CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine
FDA 510(k) K142609 · Guangzhou Wondfo Biotech Co., Ltd.
510(k) numberK142609
Submission
- Device name
- CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
Guangzhou, CN - Received
- September 16, 2014
- Decision date
- December 18, 2014
- 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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| K072062 | Ucp Multiple Drug Screen Test CupsLFG · Special | Ucp Biosciences, Inc. | 09/20/2007SE |
| K061457 | Ucp Rapid Drug Screening Tricyclic Antidepressant, Propoxyphene TestsLFG · Traditional | Ucp Biosciences, Inc. | 08/21/2006SE |
| K021526 | Acon Tca One Step Tricyclic Antidepressant Test Strip and DeviceLFG · Traditional | ACON Laboratories, Inc. | 07/17/2002SE |
| K011545 | Verdict -Ii Tca, Verdict-Ii MTDLFG · Special | Medtox Diagnostics, Inc. | 06/08/2001SE |
| K980249 | Accusign Tca, Biosign Tca, Staus DS TcaLFG · Traditional | Princeton BioMeditech Corp. | 03/13/1998SE |
| K870823 | Emit Nortriptyline AssayLFG · Traditional | Syva Co. | 03/20/1987SE |
| K861155 | Emit Desipramine AssayLFG · Traditional | Syva Co. | 05/02/1986SE |
| K853113 | TD Tricyclic AntidepressantsLFG · Traditional | Abbott Laboratories | 08/12/1985SE |
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Questions and answers
When was CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine cleared by the FDA?
CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine (K142609) received a 510(k) decision of Substantially Equivalent on December 18, 2014, 93 days after the submission was received.
What is the product code of K142609?
The FDA product code is LFG – Radioimmunoassay, Tricyclic Antidepressant Drugs, a Class II (moderate risk) device regulated under 21 CFR 862.3910.