Eurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVM
FDA 510(k) K131595 · Eurotrol B.V.
510(k) numberK131595
Submission
- Device name
- Eurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVM
- Applicant
- Eurotrol B.V.
Ede, NL - Received
- June 3, 2013
- Decision date
- July 26, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K162530 | Multichem IA PlusJJY · Abbreviated | Techno-Path Manufacturing | 03/31/2017SE |
| K163629 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 03/10/2017SE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | Bio-Rad Laboratories | 01/10/2017SE |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | Radiometer America, Inc. | 01/28/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test KitJJY · Traditional | Maine Standards Company, LLC | 04/30/2015SE |
| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
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| 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 |
| K152553 | CueSee HypoxicJJS · Traditional | 04/22/2016SE |
| 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 Eurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVM cleared by the FDA?
Eurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVM (K131595) received a 510(k) decision of Substantially Equivalent on July 26, 2013, 53 days after the submission was received.
What is the product code of K131595?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.