Drug Free Enterprises
Country not established
- Devices
- 1
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
What Drug Free Enterprises makes
Drug Free Enterprises manufactures the No Step On Site Drug Test Cup, a single-use device for on-site urine drug screening that detects the presence of controlled substances without requiring a collection container to be stepped on.
The company’s portfolio is regulated under FDA Class II devices and is listed via 510(k) clearance. The manufacturer is based in the United States.
Catalogue
No Step On Site Deug Test Cup Ref K012390
510(k) 510(k)
FDA recalls
FDA recall records list 6 recalls initiated by Drug Free Enterprises, initiated on 2003-03-20. By recorded status: 6 terminated. The reasons filed fall into these groups: labeling or instructions for use and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2003
- 20 Mar 2003 Z-0239-04 Unclassified (pre-2012) Terminated Lacks professional use labeling and firm name and address.
- 20 Mar 2003 Z-1245-03 Unclassified (pre-2012) Terminated Label lacks professional use legend and name and address of the manufacturer.
- 20 Mar 2003 Z-1246-03 Unclassified (pre-2012) Terminated Label lacks professional use legend and name and address of the manufacturer.
- 20 Mar 2003 Z-1253-03 Unclassified (pre-2012) Terminated Label lacks professional use legend and name and address of the manufacturer.
- 20 Mar 2003 Z-1254-03 Unclassified (pre-2012) Terminated Label lacks professional use legend and name and address of the manufacturer.
- 20 Mar 2003 Z-1256-03 Unclassified (pre-2012) Terminated Label lacks professional use legend and name and address of the manufacturer.
Frequently asked questions
How many devices does Drug Free Enterprises have in the registry?
The registry currently lists 1 device for Drug Free Enterprises. Devices recorded under merged duplicate company entries are counted once.
Which registries list Drug Free Enterprises's devices?
Among its 1 most recently registered device, Drug Free Enterprises has devices listed in FDA 510(k) (1 device).
What risk classes do Drug Free Enterprises's devices fall under?
Among its 1 most recently registered device, the classes recorded for Drug Free Enterprises's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Drug Free Enterprises?
FDA recall records list 6 recalls initiated by Drug Free Enterprises, the most recent initiated on 2003-03-20. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Drug Free Enterprises in the registry?
The most recently registered devices listed for Drug Free Enterprises include NO STEP ON SITE DEUG TEST CUP.