Livesure Methamphetamine Screen Tests
FDA 510(k) K011610 · Pan Probe Biotech, Inc.
510(k) numberK011610
Submission
- Device name
- Livesure Methamphetamine Screen Tests
- Applicant
- Pan Probe Biotech, Inc.
San Diego, CA, US - Received
- May 25, 2001
- Decision date
- June 8, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- LAF – Gas Chromatography, Methamphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3610
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LAF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayLAF · Traditional | Immunalysis Corporation | 12/22/2021SE |
| K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairLAF · Traditional | Psychemedics Corporation | 12/15/2021SE |
| K201442 | Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus AnalyzersLAF · Traditional | Diatron Group | 07/31/2020SE |
| K170222 | Rapid Tox Cup IILAF · Traditional | American Bio Medica Corp. | 08/15/2017SE |
| K153693 | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLAF · Traditional | Immunalysis Corporation | 03/18/2016SE |
| K142293 | Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine…LAF · Traditional | Biophor Diagnostics, Inc. | 09/18/2015SE |
| K150096 | Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test…LAF · Traditional | Healgen Scientific,, LLC | 03/04/2015SE |
| K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestLAF · Traditional | W.H.P.M., Inc. | 02/26/2015SE |
| K133047 | Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral…LAF · Traditional | Biophor Diagnostics, Inc. | 12/18/2014SE |
| K131652 | Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, ControlsLAF · Traditional | Lin-Zhi International, Inc. | 03/21/2014SE |
More from Lin-Zhi International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K020968 | Livesure HCG Urinary Pregnancy Test Strip and Test CardJHI · Traditional | 07/15/2002SE |
| K013796 | Livesure Methadone Screen TestsDJR · Traditional | 11/26/2001SE |
| K012133 | Livesure Barbiturates Screen TestDIS · Traditional | 07/20/2001SE |
| K012131 | Livesure Benzodiazepines Screen TestsJXM · Traditional | 07/20/2001SE |
| K012107 | Livesure Phenecycline (PCP) Screen TestsLCM · Traditional | 07/20/2001SE |
| K011609 | Livesure Amphetamine Screen TestDKZ · Traditional | 06/08/2001SE |
| K010967 | Livesure Cocaine Screen TestDIO · Traditional | 04/17/2001SE |
| K011011 | Livesure Morphine Screen TestDOE · Traditional | 04/13/2001SE |
| K010001 | Livesure THC Screen TestLDJ · Traditional | 02/05/2001SE |
Questions and answers
When was Livesure Methamphetamine Screen Tests cleared by the FDA?
Livesure Methamphetamine Screen Tests (K011610) received a 510(k) decision of Substantially Equivalent on June 8, 2001, 14 days after the submission was received.
What is the product code of K011610?
The FDA product code is LAF – Gas Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.