AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)
FDA 510(k) K153465 · Assure Tech. (Hangzhou) Co, Ltd.
510(k) numberK153465
Submission
- Device name
- AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)
- Applicant
- Assure Tech. (Hangzhou) Co, Ltd.
Hangzhou, CN - Received
- December 1, 2015
- Decision date
- March 31, 2016
- 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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| 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 |
| K161044 | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…DJC · Traditional | 07/06/2016SE |
Questions and answers
When was AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) cleared by the FDA?
AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) (K153465) received a 510(k) decision of Substantially Equivalent on March 31, 2016, 121 days after the submission was received.
What is the product code of K153465?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.