FDA 510(k) Applications Submitted by HONG FENG
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140215 |
01/28/2014 |
ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD |
CO-INNOVATION BIOTECH CO., LTD. |
| K140748 |
03/25/2014 |
ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD |
CO-INNOVATION BIOTECH CO.,LTD. |
| K131110 |
04/19/2013 |
ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD |
CO-INNOVATION BIOTECH CO., LTD. |
| K241100 |
04/22/2024 |
Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard |
Co-Innovation Biotech Co.,Ltd. |
| K231904 |
06/28/2023 |
Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard |
Co-Innovation Biotech Co.,Ltd. |
| K132085 |
07/05/2013 |
ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM |
CO-INNOVATION BIOTECH CO., LTD. |
| K232732 |
09/07/2023 |
Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 |
Co-Innovation Biotech Co., Ltd. |
| K142800 |
09/29/2014 |
Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard |
Co-Innovation Biotech Co., Ltd. |
| K153050 |
10/20/2015 |
Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard |
Co-Innovation Biotech Co., Ltd |
| K213808 |
12/06/2021 |
Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream |
Co-Innovation Biotech Co.,Ltd. |
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