510(k) K052027 ยท CGZ Electrode, Ion-Specific, Chloride
OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200
| Applicant | Osmetech, Inc., Roswell GA, US |
| Decision | Substantially Equivalent, Sep 29, 2005 |
| Received | Jul 27, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052027
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2013 | OPTI Medical Systems, Inc Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical
Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sod Terminated |
JJE | None listed |
| Jun 14, 2011 | OPTI Medical Systems, Inc OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box).
Cassettes are consumables used in the OPTI LION Electrolyte Analyzer intended to be used for the mea Terminated |
CGZ | None listed |
| Mar 11, 2010 | OPTI Medical Systems, Inc OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care.
Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blo Terminated |
CGZ | None listed |
| Nov 9, 2007 | Opti Medical Systems Inc OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076 Terminated |
JGS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.