Elittech Clinical Systems Alp Ifcc SL
FDA 510(k) K113269 · Elitechgroup
510(k) numberK113269
Submission
- Device name
- Elittech Clinical Systems Alp Ifcc SL
- Applicant
- Elitechgroup
Bothell, WA, US - Received
- November 4, 2011
- Decision date
- December 29, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
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Questions and answers
When was Elittech Clinical Systems Alp Ifcc SL cleared by the FDA?
Elittech Clinical Systems Alp Ifcc SL (K113269) received a 510(k) decision of Substantially Equivalent on December 29, 2011, 55 days after the submission was received.
What is the product code of K113269?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.