Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard
FDA 510(k) K142800 · Co-Innovation Biotech Co., Ltd.
510(k) numberK142800
Submission
- Device name
- Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard
- Applicant
- Co-Innovation Biotech Co., Ltd.
Guangzhou, CN - Received
- September 29, 2014
- Decision date
- December 11, 2014
- 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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| K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test DipcardNGL · Traditional | 05/22/2024SE |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardDJG · Traditional | 03/08/2024SE |
| K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid…LDJ · Traditional | 01/17/2024SE |
| K213808 | Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One…LCX · Special | 04/05/2022SE |
| K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardDJG · Special | 04/26/2016SE |
| K140748 | One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test DipcardDJG · Traditional | 08/20/2014SE |
| K140215 | One Step Single/Multi-Drug Test Cup/DipcardDIS · Traditional | 06/16/2014SE |
| K131110 | One Step Single/Multi-Drug Test Cup; One Step Single Single/Multi-Drug Test DipcardDKZ · Traditional | 01/15/2014SE |
| K132085 | One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test MidstreamLCX · Traditional | 11/12/2013SE |
Questions and answers
When was Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard cleared by the FDA?
Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard (K142800) received a 510(k) decision of Substantially Equivalent on December 11, 2014, 73 days after the submission was received.
What is the product code of K142800?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.