Coulter 4C-EX 300 Cell Control
FDA 510(k) K100607 · Beckman Coulter, Inc.
510(k) numberK100607
Submission
- Device name
- Coulter 4C-EX 300 Cell Control
- Applicant
- Beckman Coulter, Inc.
Miami, FL, US - Received
- March 3, 2010
- Decision date
- November 18, 2010
- 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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| 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 4C-EX 300 Cell Control cleared by the FDA?
Coulter 4C-EX 300 Cell Control (K100607) received a 510(k) decision of Substantially Equivalent on November 18, 2010, 260 days after the submission was received.
What is the product code of K100607?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.