Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
FDA 510(k) K150096 · Healgen Scientific,, LLC
510(k) numberK150096
Submission
- Device name
- Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
- Applicant
- Healgen Scientific,, LLC
Bellaire, TX, US - Received
- January 20, 2015
- Decision date
- March 4, 2015
- 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
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|---|---|---|---|
| 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 |
| 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 |
| K111927 | Psychemedics Methamphetamine EiaLAF · Traditional | Psychemedics Corp. | 05/01/2012SE |
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| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…NGL · Traditional | 12/23/2025SE |
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| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine…NGL · Traditional | 12/17/2024SE |
| K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl…NGL · Traditional | 05/13/2024SE |
| K232377 | Healgen Rapid COVID-19 Antigen TestQVF · Traditional | 04/19/2024SE |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…NGL · Traditional | 04/12/2024SE |
Questions and answers
When was Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) cleared by the FDA?
Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) (K150096) received a 510(k) decision of Substantially Equivalent on March 4, 2015, 43 days after the submission was received.
What is the product code of K150096?
The FDA product code is LAF – Gas Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.