FDA 510(k) Applications Submitted by Ben Chen
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150022 |
01/06/2015 |
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream |
Guangzhou Wondfo Biotech Co., Ltd. |
| K150179 |
01/27/2015 |
CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids |
GUANGZHOU WONDFO BIOTECH CO., LTD. |
| K150602 |
03/10/2015 |
CR3 Keyless Split Sample Cup Morphine - Methamphetamine |
GUANGZHOU WONDFO BIOTECH CO., LTD. |
| K151478 |
06/02/2015 |
Wondfo CR3 Keyless Split Sample Cup |
GUANGZHOU WONDFO BIOTECH CO., LTD. |
| K151557 |
06/10/2015 |
EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine |
NANTONG EGENS BIOTECH CO., LTD. |
| K152495 |
09/01/2015 |
Wondfo Propoxyphene Urine Test |
Guangzhou Wondfo Biotech Co., Ltd. |
| K142609 |
09/16/2014 |
CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine |
Guangzhou Wondfo Biotech Co., Ltd. |
| K143535 |
12/15/2014 |
CR3 Keyless Split Sample Cup Secobarbital- Methadone |
GUANGZHOU WONDFO BIOTECH CO., LTD. |
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