Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls
FDA 510(k) K131652 · Lin-Zhi International, Inc.
510(k) numberK131652
Submission
- Device name
- Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls
- Applicant
- Lin-Zhi International, Inc.
Sunnyvale, CA, US - Received
- June 5, 2013
- Decision date
- March 21, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K111927 | Psychemedics Methamphetamine EiaLAF · Traditional | Psychemedics Corp. | 05/01/2012SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | 01/16/2026SE |
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| K201938 | LZI Fentanyl II Enzyme ImmunoassayDJG · Traditional | 08/07/2020SE |
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| K192299 | LZI Cotinine II Enzyme ImmunoassayMKU · Traditional | 11/21/2019SE |
| K192433 | LZI Methadone II Enzyme ImmunoassayDJR · Traditional | 10/04/2019SE |
| K181159 | LZI Fentanyl Enzyme ImmunoassayDJG · Traditional | 12/03/2018SE |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)…DJR · Traditional | 06/26/2017SE |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…LDJ · Traditional | 05/28/2015SE |
Questions and answers
When was Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls cleared by the FDA?
Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls (K131652) received a 510(k) decision of Substantially Equivalent on March 21, 2014, 289 days after the submission was received.
What is the product code of K131652?
The FDA product code is LAF – Gas Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.