Pointcare Technologies, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Pointcare Technologies, Inc. makes
Pointcare Technologies, Inc. manufactures the Pointcare NOW System, a rapid diagnostic device for point-of-care testing, and the Flowcare System, a portable blood collection and processing device for near-patient diagnostics.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Pointcare Now System Ref K072869
Regimes: 510(k) Registry: 510(k)Flowcare System Ref K041882
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Pointcare Technologies, Inc., initiated on 2011-11-02. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 2 Nov 2011 Z-1193-2012 Unclassified (pre-2012) Terminated Stability not assured at labeled temperature 2-42C
Full distribution text
- 2 Nov 2011 Z-1193-2012 Unclassified (pre-2012) Terminated Stability not assured at labeled temperature 2-42C
Frequently asked questions
How many devices does Pointcare Technologies, Inc. have in the registry?
The registry currently lists 2 devices for Pointcare Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pointcare Technologies, Inc.'s devices?
Among its 2 most recently registered devices, Pointcare Technologies, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Pointcare Technologies, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Pointcare Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Pointcare Technologies, Inc.?
FDA recall records list 1 recall initiated by Pointcare Technologies, Inc., the most recent initiated on 2 Nov 2011. 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 Pointcare Technologies, Inc. in the registry?
The most recently registered devices listed for Pointcare Technologies, Inc. include POINTCARE NOW SYSTEM and FLOWCARE SYSTEM.