GenPrime Snap-Top Split Key Cup
FDA 510(k) K140665 · Genprime, Inc.
510(k) numberK140665
Submission
- Device name
- GenPrime Snap-Top Split Key Cup
- Applicant
- Genprime, Inc.
Spokane, WA, US - Received
- March 18, 2014
- Decision date
- December 8, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DIS – Enzyme Immunoassay, Barbiturate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3150
- Specialty
- Clinical Toxicology
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| K143535 | CR3 Keyless Split Sample Cup Secobarbital- MethadoneDIS · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 01/13/2015SE |
| K140215 | One Step Single/Multi-Drug Test Cup/DipcardDIS · Traditional | Co-Innovation Biotech Co., Ltd. | 06/16/2014SE |
| K092268 | Randox Bariturates AssayDIS · Traditional | Randox Laboratories, Ltd. | 05/25/2011SE |
| K110515 | Ucp Drug Screening Test CupsDIS · Special | Ucp Biosciences, Inc. | 04/20/2011SE |
| K070098 | Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening…DIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
| K070009 | At Home Drug Test Models, 9308T and 9308XDIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
| K062165 | Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…DIS · Traditional | Ortho-Clinical Diagnostics | 01/05/2007SE |
More from Ortho-Clinical Diagnostics
| 510(k) | Device | Decision |
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| K130082 | Genprime Drugs of Abuse Reader SystemDKZ · Traditional | 12/20/2013SE |
Questions and answers
When was GenPrime Snap-Top Split Key Cup cleared by the FDA?
GenPrime Snap-Top Split Key Cup (K140665) received a 510(k) decision of Substantially Equivalent on December 8, 2014, 265 days after the submission was received.
What is the product code of K140665?
The FDA product code is DIS – Enzyme Immunoassay, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.