CueSee Hypoxic
FDA 510(k) K152553 · Eurotrol B.V.
510(k) numberK152553
Submission
- Device name
- CueSee Hypoxic
- Applicant
- Eurotrol B.V.
Ede, NL - Received
- September 8, 2015
- Decision date
- April 22, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJS – Controls For Blood-Gases, (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150226 | Hematocrit and Metabolite QUALICHECKJJS · Traditional | Radiometer Medical Aps | 05/13/2015SE |
| K130415 | High Metabolite QualicheckJJS · Traditional | Radiometer Medical Aps | 03/26/2013SE |
| K130236 | Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3JJS · Traditional | Radiometer Medical Aps | 03/15/2013SE |
| K033063 | Mission ControlsJJS · Traditional | Diamond Diagnostics, Inc. | 12/12/2003SE |
| K022529 | Liquichek Blood Gas Plus Co-Oximeter Control (Il Synthesis Series) Levels 1,2, and 3…JJS · Traditional | Bio-Rad | 08/15/2002SE |
| K022525 | Liquichek Blood Gas Plus Co-Oximeter Control (Radiometer 700 Series) Levels, 1,2 and 3…JJS · Traditional | Bio-Rad | 08/15/2002SE |
| K003242 | Liquichek Blood Gas Plus Co-Oximeter Control (Il), Model 621,622,623JJS · Traditional | Bio-Rad | 11/30/2000SE |
| K003239 | Liquichek Blood Gas Plus Co-Oximeter Control (800 Series), MODEL504,505,506JJS · Traditional | Bio-Rad | 11/30/2000SE |
| K002866 | Liquichek Blood Gas Plus E Control Level 4, Model 574JJS · Traditional | Bio-Rad | 09/25/2000SE |
| K002865 | Liquichek Blood Gas Plus E Control, Model 576, 577, 578JJS · Traditional | Bio-Rad | 09/25/2000SE |
More from Bio-Rad
| 510(k) | Device | Decision |
|---|---|---|
| K192842 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighGGM · Traditional | 11/15/2019SE |
| K182744 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighGGM · Traditional | 02/01/2019SE |
| K131595 | Eurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVMJJY · Traditional | 07/26/2013SE |
| K121467 | Eurotrol Hematocrit ControlGLK · Traditional | 05/10/2013SE |
| K121468 | Eurotrol Gas-Ise MetabolitesJJY · Traditional | 06/22/2012SE |
| K060215 | Albu Trol, Low, Model 108.001.002; Albu Trol, High 108.002.002JJX · Traditional | 03/24/2006SE |
Questions and answers
When was CueSee Hypoxic cleared by the FDA?
CueSee Hypoxic (K152553) received a 510(k) decision of Substantially Equivalent on April 22, 2016, 227 days after the submission was received.
What is the product code of K152553?
The FDA product code is JJS – Controls For Blood-Gases, (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.