Medical Device Manufacturer · CN , Guangzhou, Guangdong

Co-Innovation Biotech Co., Ltd.

10 submissions · 10 cleared · Since 2013
10
Total
10
Cleared
0
Denied

Co-Innovation Biotech Co., Ltd. — FDA 510(k) Submissions

Co-Innovation Biotech Co., Ltd. has submitted 10 FDA 510(k) premarket notifications since 2013, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Amphetamine, Kit, Test, Pregnancy, Hcg, Over The Counter, Enzyme Immunoassay, Barbiturate, Enzyme Immunoassay, Cannabinoids . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
K241100 · NGL Test, Opiates, Over The... · Toxicology
May 2024 30d
Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
K231904 · DJG Enzyme Immunoassay, Opiates · Toxicology
Mar 2024 254d
Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
K232732 · LDJ Enzyme Immunoassay,... · Toxicology
Jan 2024 132d
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
K213808 · LCX Kit, Test, Pregnancy,... · Chemistry
Apr 2022 120d
Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
K153050 · DJG Enzyme Immunoassay, Opiates · Toxicology
Apr 2016 189d
Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard
K142800 · DKZ Enzyme Immunoassay,... · Toxicology
Dec 2014 73d
ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD
K140748 · DJG Enzyme Immunoassay, Opiates · Toxicology
Aug 2014 148d
ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD
K140215 · DIS Enzyme Immunoassay,... · Toxicology
Jun 2014 139d
ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD
K131110 · DKZ Enzyme Immunoassay,... · Toxicology
Jan 2014 271d
ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
K132085 · LCX Kit, Test, Pregnancy,... · Chemistry
Nov 2013 130d
Filters