Cholestech Corp.
United StatesFDA applicant, unverified
- Devices
- 20
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Cholestech Corp. makes
Cholestech Corp. manufactures portable lipid monitoring systems and associated test panels for measuring cholesterol levels, including total cholesterol, HDL cholesterol, triglycerides, and glucose. These devices are designed for point-of-care use, enabling rapid on-site analysis of lipid profiles and metabolic markers. Control solutions like the L.D.X. Level 1 are also provided for system calibration and quality assurance.
The company’s products are regulated under FDA’s 510(k) clearance process, with devices classified as Class I and Class II. These systems are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the United States. The manufacturer is based in the US.
Catalogue
Search and filter all 20 devicesFDA recalls
FDA recall records list 2 recalls initiated by Cholestech Corp., the earliest on 2006-08-03 and the most recent on 2006-08-09. By recorded status: 2 terminated. The reasons filed fall into these groups: sterility or contamination, performance or accuracy 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.
2006
- 9 Aug 2006 Z-2457-2008 Unclassified (pre-2012) Terminated Test results are high, outside of control material upper limit specification. Results could be as high as 15%.
Full distribution text
- 3 Aug 2006 Z-2460-2008 Unclassified (pre-2012) Terminated Cholestech Corp. was notified by the foreign manufacturer of the A1C test cartridge that stability data indicated that the product would not meet performance claims through the end of its shelf life.
- 9 Aug 2006 Z-2457-2008 Unclassified (pre-2012) Terminated Test results are high, outside of control material upper limit specification. Results could be as high as 15%.
Frequently asked questions
How many devices does Cholestech Corp. have in the registry?
The registry currently lists 20 devices for Cholestech Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cholestech Corp.'s devices?
Among its 20 most recently registered devices, Cholestech Corp. has devices listed in FDA 510(k) (20 devices).
What risk classes do Cholestech Corp.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Cholestech Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Cholestech Corp.?
FDA recall records list 2 recalls initiated by Cholestech Corp., the most recent initiated on 9 Aug 2006. 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 Cholestech Corp. in the registry?
The most recently registered devices listed for Cholestech Corp. include CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE, TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL, TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL and CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST.