Opti Lion Electrolyte Analyzer, Model GD7200
FDA 510(k) K052027 · Osmetech, Inc.
510(k) numberK052027
Submission
- Device name
- Opti Lion Electrolyte Analyzer, Model GD7200
- Applicant
- Osmetech, Inc.
Roswell, GA, US - Received
- July 27, 2005
- Decision date
- September 29, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGZ – Electrode, Ion-Specific, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
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Questions and answers
When was Opti Lion Electrolyte Analyzer, Model GD7200 cleared by the FDA?
Opti Lion Electrolyte Analyzer, Model GD7200 (K052027) received a 510(k) decision of Substantially Equivalent on September 29, 2005, 64 days after the submission was received.
What is the product code of K052027?
The FDA product code is CGZ – Electrode, Ion-Specific, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.