Osmetech, Inc.
Country not established
- Devices
- 4
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Osmetech, Inc. makes
Osmetech, Inc. manufactures electrolyte analyzers, including the OPTI LION GD7200 and the OPTI R GD7044 designed for critical care settings. These devices measure electrolyte levels in blood samples, supporting clinical decision-making in hospital environments.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via 510(k) clearance. Osmetech, Inc. is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Opti Lion Electrolyte Analyzer, Model GD7200 Ref K052027
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Osmetech, Inc., initiated on 2004-06-22. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 22 Jun 2004 Z-1064-04 Unclassified (pre-2012) Terminated In some cases patient samples with high glucose concentrations, above the reportable range of the OPTI-CCA Analyzer, may be erroneously reported as 'Low'.
Full distribution text
- 22 Jun 2004 Z-1064-04 Unclassified (pre-2012) Terminated In some cases patient samples with high glucose concentrations, above the reportable range of the OPTI-CCA Analyzer, may be erroneously reported as 'Low'.
Frequently asked questions
How many devices does Osmetech, Inc. have in the registry?
The registry currently lists 4 devices for Osmetech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Osmetech, Inc.'s devices?
Among its 4 most recently registered devices, Osmetech, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Osmetech, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Osmetech, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Osmetech, Inc.?
FDA recall records list 1 recall initiated by Osmetech, Inc., the most recent initiated on 22 Jun 2004. 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 Osmetech, Inc. in the registry?
The most recently registered devices listed for Osmetech, Inc. include OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV), OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200, OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) and OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044.