CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
FDA 510(k) K161251 · Hangzhou Clongene Biotech Co., Ltd.
510(k) numberK161251
Submission
- Device name
- CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
- Applicant
- Hangzhou Clongene Biotech Co., Ltd.
Hangzhou, CN - Received
- May 3, 2016
- Decision date
- August 30, 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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Questions and answers
When was CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests cleared by the FDA?
CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests (K161251) received a 510(k) decision of Substantially Equivalent on August 30, 2016, 119 days after the submission was received.
What is the product code of K161251?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.