Advin Multi-Drug Screen Test Cassette, Dip Card and Cup
FDA 510(k) K122809 · Advin Biotech
510(k) numberK122809
Submission
- Device name
- Advin Multi-Drug Screen Test Cassette, Dip Card and Cup
- Applicant
- Advin Biotech
San Diego, CA, US - Received
- September 13, 2012
- Decision date
- June 17, 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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| K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395ZDKZ · Traditional | Phamatech, Inc. | 10/18/2018SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K252867 | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupNFT · Traditional | 10/09/2025SE |
| K201494 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardDJG · Traditional | 09/17/2020SE |
| K182123 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardDJG · Traditional | 03/29/2019SE |
Questions and answers
When was Advin Multi-Drug Screen Test Cassette, Dip Card and Cup cleared by the FDA?
Advin Multi-Drug Screen Test Cassette, Dip Card and Cup (K122809) received a 510(k) decision of Substantially Equivalent on June 17, 2013, 277 days after the submission was received.
What is the product code of K122809?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.