Co-Innovation Biotech Co.,Ltd.
Guangzhou Guangdong, CN
CO-INNOVATION BIOTECH CO.,LTD. appears in FDA device records in Guangzhou Guangdong, CN. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Co-Innovation Biotech Co.,Ltd. between 2013 and 2024. The busiest year on record is 2014, with 4. The most recent is 2024, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2014 | 4 |
| 2016 | 1 |
| 2022 | 1 |
| 2024 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard | NGL | Substantially Equivalent | |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard | DJG | Substantially Equivalent | |
| K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 | LDJ | Substantially Equivalent | |
| K213808 | 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 | LCX | Substantially Equivalent | |
| K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard | DJG | Substantially Equivalent | |
| K142800 | Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard | DKZ | Substantially Equivalent | |
| K140748 | ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD | DJG | Substantially Equivalent | |
| K140215 | ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD | DIS | Substantially Equivalent | |
| K131110 | ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD | DKZ | Substantially Equivalent | |
| K132085 | ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM | LCX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010220539 | 3010220539 | CO-INNOVATION BIOTECH CO.,LTD. | No. 9 Baihe 3 street, Economic and Technological Development East Zone,, Guangzhou Guangdong 510530 CN | 2026 | and 19 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- LAFGas Chromatography, Methamphetamine
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- CEPRadioimmunoassay, Luteinizing Hormone
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- MRSTest System, Nicotine, Cotinine, Metabolites
- NFTTest, Amphetamine, Over The Counter
- PTHTest, Barbiturate, Over The Counter
- NFVTest, Benzodiazepine, Over The Counter
- NFWTest, Cannabinoid, Over The Counter
- NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
- PTGTest, Methadone, Over The Counter
- NGGTest, Methamphetamine, Over The Counter
- NGITest, Morphine, Over The Counter
- NGLTest, Opiates, Over The Counter
- NGMTest, Phencyclidine (Pcp), Over The Counter
- QBFTest, Propoxyphene, Over The Counter
- QAWTest, Tricyclic Antidepressants, Over The Counter
- DJCThin Layer Chromatography, Methamphetamine
- DNKThin Layer Chromatography, Morphine
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Co-Innovation Biotech Co.,Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain