Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral Fluid Controls, Rapidease Oral Flu
FDA 510(k) K133047 · Biophor Diagnostics, Inc.
510(k) numberK133047
Submission
- Device name
- Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral Fluid Controls, Rapidease Oral Flu
- Applicant
- Biophor Diagnostics, Inc.
Redwood City, CA, US - Received
- September 27, 2013
- Decision date
- December 18, 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 |
| 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 |
More from Psychemedics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K142293 | Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine…LAF · Traditional | 09/18/2015SE |
| K142129 | Rapidfret Oral Fluid Assay for Cocaine, Rapidfret Oral Fluid Cocaine Calibrator Set…DIO · Traditional | 07/24/2015SE |
| K141748 | Rapidfret Oral Fluid Assay for Amphetamine, Rapidfret Oral Fluid Amphetamine Calibrator…DKZ · Traditional | 05/20/2015SE |
| K133642 | Rapidfret Oral Fluid Assay for Opiates; Rapidfret Oral Fluid Calibrators, Controls…DJG · Traditional | 01/24/2014SE |
| K132096 | Rapidfret Oral Fluid Assay for THC, THC Calibrator Set, THC Control Set, CollectorLDJ · Traditional | 10/18/2013SE |
| K122703 | Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease…LCM · Traditional | 04/25/2013SE |
Questions and answers
When was Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral Fluid Controls, Rapidease Oral Flu cleared by the FDA?
Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral Fluid Controls, Rapidease Oral Flu (K133047) received a 510(k) decision of Substantially Equivalent on December 18, 2014, 447 days after the submission was received.
What is the product code of K133047?
The FDA product code is LAF – Gas Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.