Fsc Laboratories, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Fsc Laboratories, Inc. makes
Fsc Laboratories, Inc. manufactures anti-static valved collapsible holding chambers, designed for controlled containment of medical or laboratory specimens while preventing static electricity buildup.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance. The products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
- 510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Fsc Laboratories, Inc., initiated on 2016-05-16. By recorded status: 1 terminated. The reasons filed fall into these groups: packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 16 May 2016 Z-1995-2016 Class II Terminated Product had torn/loose seal around the mouthpiece.
Frequently asked questions
How many devices does Fsc Laboratories, Inc. have in the registry?
The registry currently lists 1 device for Fsc Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fsc Laboratories, Inc.'s devices?
Among its 1 most recently registered device, Fsc Laboratories, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Fsc Laboratories, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Fsc Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Fsc Laboratories, Inc.?
FDA recall records list 1 recall initiated by Fsc Laboratories, Inc., the most recent initiated on 2016-05-16. 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 Fsc Laboratories, Inc. in the registry?
The most recently registered devices listed for Fsc Laboratories, Inc. include FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER.