Ise Indirect Na, K, CL for GEN.2
FDA 510(k) K053165 · Roche Diagnostics Corp.
510(k) numberK053165
Submission
- Device name
- Ise Indirect Na, K, CL for GEN.2
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- November 14, 2005
- Decision date
- December 14, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
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Questions and answers
When was Ise Indirect Na, K, CL for GEN.2 cleared by the FDA?
Ise Indirect Na, K, CL for GEN.2 (K053165) received a 510(k) decision of Substantially Equivalent on December 14, 2005, 30 days after the submission was received.
What is the product code of K053165?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.