First Check Home Drug Test Panel 4
FDA 510(k) K993852 · Worldwide Medical Corp.
510(k) numberK993852
Submission
- Device name
- First Check Home Drug Test Panel 4
- Applicant
- Worldwide Medical Corp.
Washington, DC, US - Received
- November 12, 1999
- Decision date
- November 29, 2000
- 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 |
|---|---|---|
| K051966 | First Check Multi Drug Cup 7 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp)…DKZ · Traditional | 09/07/2005SE |
| K020869 | First Check Home Drug Test for Mdma (Ecstasy)DKZ · Traditional | 06/11/2002SE |
| K994139 | First Check Home Drug Test Panel 2LDJ · Traditional | 06/23/2000SE |
| K994138 | First Check Home Drug Test Panel 3LDJ · Traditional | 06/23/2000SE |
| K993663 | First Check Home Drug Test (THC)LDJ · Traditional | 06/23/2000SE |
| K912270 | Polycath #WMC-900DQO · Traditional | 08/05/1992SE |
| K894401 | Balloon Thermodilution CathetersDQO · Traditional | 04/19/1990SE |
| K891843 | Rank Patient Exam Gloves (Mfg. Inter-Continental)LYY · Traditional | 06/06/1989SE |
Questions and answers
When was First Check Home Drug Test Panel 4 cleared by the FDA?
First Check Home Drug Test Panel 4 (K993852) received a 510(k) decision of Substantially Equivalent on November 29, 2000, 383 days after the submission was received.
What is the product code of K993852?
The FDA product code is LAF – Gas Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.