Cedia Dau Amphetamines/Ecstasy Assay
FDA 510(k) K010496 · Microgenics Corp.
510(k) numberK010496
Submission
- Device name
- Cedia Dau Amphetamines/Ecstasy Assay
- Applicant
- Microgenics Corp.
Fremont Blvd., CA, US - Received
- February 21, 2001
- Decision date
- May 29, 2001
- 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 |
| 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 |
|---|---|---|
| K243498 | Alinity c Benzodiazepines Reagent KitJXM · Special | 12/11/2024SE |
| K240670 | DRI Ecstasy Plus AssayDKZ · Special | 10/30/2024SE |
| K231020 | Alinity c Tricyclic Antidepressants Reagent KitLFH · Traditional | 11/17/2023SE |
| K231007 | CEDIA Heroin Metabolite (6-AM) AssayDJG · Traditional | 09/27/2023SE |
| K213875 | DRI TM Tricyclics Serum Tox AssayLFH · Traditional | 12/21/2022SE |
| K211973 | DRI Cocaine Metabolite AssayDIO · Traditional | 09/24/2021SE |
| K192943 | CEDIA Heroin Metabolite (6-AM) assayDJG · Traditional | 12/16/2019SE |
| K190968 | CEDIA Benzodiazepine AssayJXM · Traditional | 12/09/2019SE |
| K181499 | DRI Cocaine Metabolite AssayDIO · Traditional | 07/06/2018SE |
| K173963 | DRI Benzodiazepine AssayJXM · Traditional | 02/21/2018SE |
Questions and answers
When was Cedia Dau Amphetamines/Ecstasy Assay cleared by the FDA?
Cedia Dau Amphetamines/Ecstasy Assay (K010496) received a 510(k) decision of Substantially Equivalent on May 29, 2001, 97 days after the submission was received.
What is the product code of K010496?
The FDA product code is LAF – Gas Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.