First Check Home Drug Test (THC)
FDA 510(k) K993663 · Worldwide Medical Corp.
510(k) numberK993663
Submission
- Device name
- First Check Home Drug Test (THC)
- Applicant
- Worldwide Medical Corp.
Washington, DC, US - Received
- October 29, 1999
- Decision date
- June 23, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LDJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid…LDJ · Traditional | Co-Innovation Biotech Co., Ltd. | 01/17/2024SE |
| K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit…LDJ · Traditional | Hangzhou Laihe Biotech Co., Ltd. | 01/10/2024SE |
| K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTLDJ · Traditional | Healgen Scientific,, LLC | 03/17/2023SE |
| K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…LDJ · Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. | 10/11/2019SE |
| K153741 | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana TestLDJ · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 03/18/2016SE |
| K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test…LDJ · Traditional | Nantong Egens Biotech Co., Ltd. | 11/02/2015SE |
| K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators…LDJ · Traditional | Immunalysis Corporation | 06/05/2015SE |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…LDJ · Traditional | Lin-Zhi International, Inc. | 05/28/2015SE |
| K142408 | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep…LDJ · Traditional | Polymed Therapeutics, Inc. | 09/25/2014SE |
| K140546 | Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine TestLDJ · Traditional | Healgen Scientific,, LLC | 06/06/2014SE |
More from Healgen Scientific,, LLC
| 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 |
| K993852 | First Check Home Drug Test Panel 4LAF · Traditional | 11/29/2000SE |
| K994139 | First Check Home Drug Test Panel 2LDJ · Traditional | 06/23/2000SE |
| K994138 | First Check Home Drug Test Panel 3LDJ · 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 (THC) cleared by the FDA?
First Check Home Drug Test (THC) (K993663) received a 510(k) decision of Substantially Equivalent on June 23, 2000, 238 days after the submission was received.
What is the product code of K993663?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.