Genprime Drugs of Abuse Reader System
FDA 510(k) K130082 · Genprime, Inc.
510(k) numberK130082
Submission
- Device name
- Genprime Drugs of Abuse Reader System
- Applicant
- Genprime, Inc.
Oms River, NJ, US - Received
- January 14, 2013
- Decision date
- December 20, 2013
- 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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| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…DKZ · Traditional | Alfa Scientific Designs, Inc. | 02/23/2018SE |
More from Alfa Scientific Designs, Inc.
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| K140665 | GenPrime Snap-Top Split Key CupDIS · Traditional | 12/08/2014SE |
Questions and answers
When was Genprime Drugs of Abuse Reader System cleared by the FDA?
Genprime Drugs of Abuse Reader System (K130082) received a 510(k) decision of Substantially Equivalent on December 20, 2013, 340 days after the submission was received.
What is the product code of K130082?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.