Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)
FDA 510(k) K151348 · Healgen Scientific,, LLC
510(k) numberK151348
Submission
- Device name
- Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)
- Applicant
- Healgen Scientific,, LLC
Bellaire, TX, US - Received
- May 20, 2015
- Decision date
- August 18, 2015
- 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.
Other 510(k)s with product code LFG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142609 | CR3 Keyless Split Sample Cup Nortriptyline-BuprenorphineLFG · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 12/18/2014SE |
| K112395 | Wondfo Phencyclidine Urine Test, Tricyclic Antidepressants Urine TestLFG · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 09/09/2011SE |
| 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 Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) cleared by the FDA?
Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) (K151348) received a 510(k) decision of Substantially Equivalent on August 18, 2015, 90 days after the submission was received.
What is the product code of K151348?
The FDA product code is LFG – Radioimmunoassay, Tricyclic Antidepressant Drugs, a Class II (moderate risk) device regulated under 21 CFR 862.3910.