JPK — Mixture, Hematology Quality Control Class II
FDA Device Classification
Classification Details
- Product Code
- JPK
- Device Class
- Class II
- Regulation Number
- 864.8625
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K160590 | streck | XN CHECK | December 22, 2016 |
| K160588 | streck | XN CHECK BF | December 22, 2016 |
| K160586 | streck | XN-L CHECK | December 22, 2016 |
| K160606 | r and d systems | BC-5D Hematology Control | September 1, 2016 |
| K141964 | streck | XN CHECK | December 5, 2014 |
| K141957 | streck | XN CHECK BF | December 5, 2014 |
| K130962 | r and d systems | R&D 5D RETIC HEMATOLOGY CONTROL | July 24, 2013 |
| K120744 | streck | XN CHECK BF | October 19, 2012 |
| K120742 | streck | XN CHECK | October 19, 2012 |
| K101578 | r and d systems | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL | April 28, 2011 |
| K100790 | beckman coulter | COULTER LIN-X LINEARITY CONTROL, MODEL A81196 | December 21, 2010 |
| K100607 | beckman coulter | COULTER 4C-EX 300 CELL CONTROL | November 18, 2010 |
| K091303 | bio-rad laboratories | LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV | August 2, 2010 |
| K100050 | r and d systems | R & D SYSTEMS XERET HEMATOLOGY CONTROL | January 29, 2010 |
| K091433 | r and d systems | R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL | October 28, 2009 |
| K090201 | streck | UA-CELLULAR FOR IQ | March 27, 2009 |
| K082162 | beckman coulter | COULTER BODY FLUID CONTROL | February 3, 2009 |
| K081822 | beckman coulter | COULTER 6C CELL CONTROL, MODELS 628027 & A59925 | January 21, 2009 |
| K081641 | beckman coulter | COULTER LIN-X LINEARITY CONTROL | January 16, 2009 |
| K073178 | r and d systems | HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 | December 27, 2007 |