Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma, Methadone, Opiates, Phencyclidine & Cannabinoids
FDA 510(k) K050394 · Medtox Diagnostics, Inc.
510(k) numberK050394
Submission
- Device name
- Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma, Methadone, Opiates, Phencyclidine & Cannabinoids
- Applicant
- Medtox Diagnostics, Inc.
Burlington, NC, US - Received
- February 16, 2005
- Decision date
- October 25, 2005
- 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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Questions and answers
When was Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma, Methadone, Opiates, Phencyclidine & Cannabinoids cleared by the FDA?
Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma, Methadone, Opiates, Phencyclidine & Cannabinoids (K050394) received a 510(k) decision of Substantially Equivalent on October 25, 2005, 251 days after the submission was received.
What is the product code of K050394?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.