Coulter Lin-X Linearity Control
FDA 510(k) K081641 · Beckman Coulter, Inc.
510(k) numberK081641
Submission
- Device name
- Coulter Lin-X Linearity Control
- Applicant
- Beckman Coulter, Inc.
Miami, FL, US - Received
- June 11, 2008
- Decision date
- January 16, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JPK – Mixture, Hematology Quality Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
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| K160590 | XN CheckJPK · Traditional | Streck | 12/22/2016SE |
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| K160606 | BC-5D Hematology ControlJPK · Traditional | R&D Systems, Inc. | 09/01/2016SE |
| K141964 | XN CheckJPK · Traditional | Streck | 12/05/2014SE |
| K141957 | XN Check BFJPK · Traditional | Streck | 12/05/2014SE |
| K130962 | R&D 5D Retic Hematology ControlJPK · Special | R&D Systems, Inc. | 07/24/2013SE |
| K120744 | XN Check BFJPK · Traditional | Streck | 10/19/2012SE |
| K120742 | XN CheckJPK · Traditional | Streck | 10/19/2012SE |
| K101578 | R&D Systems Body Fluid-I Hematology ControlJPK · Traditional | R&D Systems, Inc. | 04/28/2011SE |
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Questions and answers
When was Coulter Lin-X Linearity Control cleared by the FDA?
Coulter Lin-X Linearity Control (K081641) received a 510(k) decision of Substantially Equivalent on January 16, 2009, 219 days after the submission was received.
What is the product code of K081641?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.