First Check Home Drug Test for Mdma (Ecstasy)
FDA 510(k) K020869 · Worldwide Medical Corp.
510(k) numberK020869
Submission
- Device name
- First Check Home Drug Test for Mdma (Ecstasy)
- Applicant
- Worldwide Medical Corp.
Lake Forest, CA, US - Received
- March 18, 2002
- Decision date
- June 11, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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|---|---|---|
| K051966 | First Check Multi Drug Cup 7 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp)…DKZ · Traditional | 09/07/2005SE |
| 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 |
| 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 for Mdma (Ecstasy) cleared by the FDA?
First Check Home Drug Test for Mdma (Ecstasy) (K020869) received a 510(k) decision of Substantially Equivalent on June 11, 2002, 85 days after the submission was received.
What is the product code of K020869?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.