Eurotrol Hematocrit Control
FDA 510(k) K121467 · Eurotrol B.V.
510(k) numberK121467
Submission
- Device name
- Eurotrol Hematocrit Control
- Applicant
- Eurotrol B.V.
Ede, NL - Received
- May 17, 2012
- Decision date
- May 10, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GLK – Control, Hematocrit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
Other 510(k)s with product code GLK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K021924 | Medica Easyqc Hematocrit ControlGLK · Traditional | Bionostics, Inc. | 06/24/2002SE |
| K020618 | Aalto Scientific Mirco Hematocrit ControlGLK · Traditional | Aalto Scientific, Ltd. | 05/14/2002SE |
| K964452 | HematachekGLK · Traditional | Richmond Diagnostics, Inc. | 02/20/1997SE |
| K961807 | Certain HCT Level a & Level B/Cvm HCT Levels 1,2,3, & 4GLK · Traditional | Ciba Corning Diagnostics Corp. | 07/26/1996SE |
| K924926 | Msi-HctGLK · Traditional | Medical Specialties, Inc. | 01/07/1993SE |
| K893562 | A.Qc HCT Level 1 and 2GLK · Traditional | Johnson & Johnson Professionals, Inc. | 07/14/1989SE |
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| K182744 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighGGM · Traditional | 02/01/2019SE |
| K152553 | CueSee HypoxicJJS · Traditional | 04/22/2016SE |
| K131595 | Eurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVMJJY · Traditional | 07/26/2013SE |
| 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 Hematocrit Control cleared by the FDA?
Eurotrol Hematocrit Control (K121467) received a 510(k) decision of Substantially Equivalent on May 10, 2013, 358 days after the submission was received.
What is the product code of K121467?
The FDA product code is GLK – Control, Hematocrit, a Class II (moderate risk) device regulated under 21 CFR 864.8625.