Submission Details
| 510(k) Number | K161251 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 03, 2016 |
| Decision Date | August 30, 2016 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
Aug 2016
Decision
119d
Days
Class 2
Risk
About This 510(k) Submission
K161251 is an FDA 510(k) clearance for the CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Hangzhou Clongene Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 30, 2016, 119 days after receiving the submission on May 3, 2016. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.
Device Classification
| Product Code | DKZ — Enzyme Immunoassay, Amphetamine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3100 |
Manufacturer
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