Cell-Dyn Brand Hematology Reagents
FDA 510(k) K852372 · Abbott Diagnostics
510(k) numberK852372
Submission
- Device name
- Cell-Dyn Brand Hematology Reagents
- Applicant
- Abbott Diagnostics
Mountain View, CA, US - Received
- June 4, 1985
- Decision date
- September 3, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K964185 | Imx Ca 125LTK · Traditional | 11/04/1997SE |
| K972182 | Abbott Strep a ControlsMJZ · Traditional | 08/13/1997SE |
| K961439 | Abbott Cell-Dyn 4000 SystemGKZ · Traditional | 10/18/1996SE |
| K890491 | Cell-Dyn 3000 Multi-Parameter Hematology AnalyerGKZ · Traditional | 04/18/1989SE |
| K881242 | Cell-Dyn Rapid-Lyse and HemogloblinGJZ · Traditional | 04/21/1988SE |
| K881130 | Cell-Dyn Isotonic DiluentGIF · Traditional | 03/31/1988SE |
| K873348 | Cell-Dyn Diff Screen, Auto. & Semi Auto. Lytic Ag.GGK · Traditional | 09/09/1987SE |
| K873347 | Cell-Dyn Diff. Screen Isotonic DiluentGIF · Traditional | 09/09/1987SE |
| K873408 | Model 690 SpectrophotometerJJQ · Traditional | 09/08/1987SE |
| K872761 | Cell-Dyn 610 Hematology AnalyzerGKZ · Traditional | 08/06/1987SE |
Questions and answers
When was Cell-Dyn Brand Hematology Reagents cleared by the FDA?
Cell-Dyn Brand Hematology Reagents (K852372) received a 510(k) decision of Substantially Equivalent on September 3, 1985, 91 days after the submission was received.
What is the product code of K852372?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.