OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200
FDA 510(k) clearance K052027 · decided 2005-09-29
Clearance details
- K-number
- K052027
- Device name
- OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200
- Applicant
- Osmetech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-27
- Decision date
- 2005-09-29
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- CGZ
- Device class
- 2
- Regulation number
- 862.1170
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Roswell, GA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Osmetech
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Casse recall (Z-0029-2014) | OPTI Medical Systems, Inc | 2013-10-18 |
| OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes pe recall (Z-2558-2011) | OPTI Medical Systems, Inc | 2011-06-14 |
| OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended recall (Z-1083-2010) | OPTI Medical Systems, Inc | 2010-03-11 |
| OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical recall (Z-0119-2008) | Opti Medical Systems Inc | 2007-11-09 |