Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797
FDA 510(k) K091216 · Siemens Healthcare Diagnostics
510(k) numberK091216
Submission
- Device name
- Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797
- Applicant
- Siemens Healthcare Diagnostics
Norowood, MA, US - Received
- April 27, 2009
- Decision date
- October 9, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1340
- Specialty
- Clinical Chemistry
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Questions and answers
When was Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 cleared by the FDA?
Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 (K091216) received a 510(k) decision of Substantially Equivalent on October 9, 2009, 165 days after the submission was received.
What is the product code of K091216?
The FDA product code is JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative), a Class II (moderate risk) device regulated under 21 CFR 862.1340.