FDA Device Entity Profile: APEX BIOTECHNOLOGY CORP.

Known Identifiers & Locations

FEI Numbers 3002671736

Owner Operator Numbers 9034629

Locations Covered HSINCHU, TW

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
9616936	APEX BIOTECHNOLOGY CORP.	HSINCHU, TW	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K150396	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.