OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200— 510(k) K052027
Substantially EquivalentOsmetech, Inc.
FDA 510(k) clearance K052027 for OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200, Substantially Equivalent on 2005-09-29. Applicant: Osmetech, Inc.. Device class: 2.
Clearance details
- Applicant
- Osmetech, Inc.
- Product code
- Code CGZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1170
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roswell, GA, US
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More clearances from Osmetech, Inc.
view allRecalls naming K052027
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052027.
Data sourced from openFDA. This site is unofficial and independent of the FDA.