Indiko
FDA 510(k) K110035 · Thermofisher Scientific OY
510(k) numberK110035
Submission
- Device name
- Indiko
- Applicant
- Thermofisher Scientific OY
Vantaa, FI - Received
- January 5, 2011
- Decision date
- June 28, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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|---|---|---|
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| K073191 | Alkaline Phosphatase (Ifcc) Plus, Ecal, Nortrol, AbtrolCJE · Traditional | 02/28/2008SE |
| K070824 | Creatinine (Enzymatic)JFY · Traditional | 12/03/2007SE |
| K071340 | Carbon Dioxide (CO2), Scal, Nortrol and AbtrolKHS · Traditional | 10/05/2007SE |
| K071580 | Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and AbtrolCIT · Traditional | 10/03/2007SE |
Questions and answers
When was Indiko cleared by the FDA?
Indiko (K110035) received a 510(k) decision of Substantially Equivalent on June 28, 2011, 174 days after the submission was received.
What is the product code of K110035?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.