PX Coulter(R) Cell Control
FDA 510(k) K912133 · Coulter Electronics, Inc.
510(k) numberK912133
Submission
- Device name
- PX Coulter(R) Cell Control
- Applicant
- Coulter Electronics, Inc.
Hialeah, FL, US - Received
- May 14, 1991
- Decision date
- July 17, 1991
- 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
Other 510(k)s with product code JPK
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|---|---|---|---|
| K160590 | XN CheckJPK · Traditional | Streck | 12/22/2016SE |
| K160588 | XN Check BFJPK · Traditional | Streck | 12/22/2016SE |
| K160586 | Xn-L CheckJPK · Traditional | Streck | 12/22/2016SE |
| 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 |
More from R&D Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K923951 | CD8 Cytospheres KitMAM · Traditional | 04/25/1994SE |
| K930119 | Coulter Retic-C Cell ControlJPK · Traditional | 04/05/1993SE |
| K921279 | CD4 Cytospheres KitGKZ · Traditional | 12/29/1992SE |
| K923530 | Coulter Multi-Q-PrepGKH · Traditional | 10/14/1992SE |
| K922181 | Coulter MH009GKZ · Traditional | 08/17/1992SE |
| K922704 | Coulter Maxm W/ AutoloaderGKZ · Traditional | 07/27/1992SE |
| K921567 | Coulter MH017GKZ · Traditional | 07/06/1992SE |
| K911385 | Coulter(R) MH010GKZ · Traditional | 06/17/1991SE |
| K905771 | Coulter Dart Ast (Got) ReagentCIT · Traditional | 02/26/1991SE |
| K905767 | Coulter Dart Alt (GPT) ReagentCKA · Traditional | 01/25/1991SE |
Questions and answers
When was PX Coulter(R) Cell Control cleared by the FDA?
PX Coulter(R) Cell Control (K912133) received a 510(k) decision of Substantially Equivalent on July 17, 1991, 64 days after the submission was received.
What is the product code of K912133?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.