Chrysalis Intelligence · Sponsors · Co-Innovation Biotech Co., Ltd.

Co-Innovation Biotech Co., Ltd.

Guangzhou, CN · 4 510(k) clearances

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Total clearances
4
2022-04-05 → 2024-05-22
Last 12 months
0
Product codes
4
Most recent
2024-05-22
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NGL Test, Opiates, Over The Counter Class II Clinical Toxicology 1 2024-05-22
DJG Enzyme Immunoassay, Opiates Class II Clinical Toxicology 1 2024-03-08
LDJ Enzyme Immunoassay, Cannabinoids Class II Clinical Toxicology 1 2024-01-17
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Class II Clinical Chemistry 1 2022-04-05
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2024-05-22 K241100 Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard NGL Class II Clinical Toxicology
2024-03-08 K231904 Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard DJG Class II Clinical Toxicology
2024-01-17 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 Class II Clinical Toxicology
2022-04-05 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 Class II Clinical Chemistry
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence