Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test Device
FDA 510(k) K011672 · ACON Laboratories, Inc.
510(k) numberK011672
Submission
- Device name
- Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test Device
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- May 30, 2001
- Decision date
- July 31, 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
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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 |
| 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 |
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Questions and answers
When was Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test Device cleared by the FDA?
Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test Device (K011672) received a 510(k) decision of Substantially Equivalent on July 31, 2001, 62 days after the submission was received.
What is the product code of K011672?
The FDA product code is LAF – Gas Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.