AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
FDA 510(k) K161044 · Assure Tech. (Hangzhou) Co, Ltd.
510(k) numberK161044
Submission
- Device name
- AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
- Applicant
- Assure Tech. (Hangzhou) Co, Ltd.
Hangzhou, CN - Received
- April 13, 2016
- Decision date
- July 6, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJC – Thin Layer Chromatography, Methamphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3610
- Specialty
- Clinical Toxicology
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| K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube)DJC · Traditional | Hangzhou Laihe Biotech Co., Ltd. | 03/18/2025SE |
| K180878 | BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test…DJC · Traditional | Shanghai Venture Bio-Tech Co., Ltd. | 12/17/2018SE |
| K181305 | OralTox Oral fluid Drug TestDJC · Traditional | Premier Biotech, Inc. | 09/20/2018SE |
| K171403 | OralTox Oral Fluid Drug TestDJC · Traditional | Premier Biotech, Inc. | 02/02/2018SE |
| K132630 | Wondfo Oxazepam Urine Test (Bzo 200) and Wondfo Methamphetamine Urine Test (Met 300)DJC · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 09/27/2013SE |
| K080347 | Uniscan -Doa SystemDJC · Traditional | Taiwan Unison Biotech, Inc. | 10/09/2008SE |
| K060355 | Acro Biotech LLC Rapid Mdma Urine Test, Catalog MDMA0010000DJC · Traditional | Acro Biotech, LLC | 08/07/2006SE |
| K060896 | Modification to Ontrak Testcup II and Onsite CupkitDJC · Traditional | Varian, Inc. | 06/09/2006SE |
| K053033 | Acro Biotech LLC Rapid Methamphetamine Urine Test; Catalog# MET001000DJC · Traditional | Acro Biotech, LLC | 06/06/2006SE |
More from Acro Biotech, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K233174 | FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test MidstreamLCX · Traditional | 02/05/2024SE |
| K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup TestsDJG · Traditional | 08/12/2021SE |
| K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT · Traditional | 08/20/2018SE |
| K180349 | AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT · Traditional | 04/05/2018SE |
| K170049 | AssureTech Panel Dip Test, AssureTech Quick Cup TestNFT · Traditional | 05/02/2017SE |
| K153465 | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)…DKZ · Traditional | 03/31/2016SE |
Questions and answers
When was AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) cleared by the FDA?
AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (K161044) received a 510(k) decision of Substantially Equivalent on July 6, 2016, 84 days after the submission was received.
What is the product code of K161044?
The FDA product code is DJC – Thin Layer Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.