Meretek Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Meretek Diagnostics, Inc. makes
Meretek Diagnostics, Inc. produces breath test devices and collection kits for detecting *Helicobacter pylori* infection, including the UBIT UBT for *H. pylori* and associated breath test systems.
These devices are classified as Class I under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Breathtek - Ubit Ubt For H. Pylori Ref K014225
Regimes: 510(k) Registry: 510(k)The Meretek Ubt Breath Test For H.pylori Ref K972352
Regimes: 510(k) Registry: 510(k)Meretek Breath Test For H.pylori Collection Kit Ref K952220
Regimes: 510(k) Registry: 510(k)
FDA recalls
2007
- 2 May 2007 Z-0003-2008 Unclassified (pre-2012) Terminated Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.
Frequently asked questions
How many devices does Meretek Diagnostics, Inc. have in the registry?
The registry currently lists 3 devices for Meretek Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Meretek Diagnostics, Inc.'s devices?
Among its 3 most recently registered devices, Meretek Diagnostics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Meretek Diagnostics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Meretek Diagnostics, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Meretek Diagnostics, Inc.?
FDA recall records list 1 recall initiated by Meretek Diagnostics, Inc., the most recent initiated on 2 May 2007. 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 Meretek Diagnostics, Inc. in the registry?
The most recently registered devices listed for Meretek Diagnostics, Inc. include BREATHTEK - UBIT UBT FOR H. PYLORI, THE MERETEK UBT BREATH TEST FOR H.PYLORI and MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT.