JPK — Mixture, Hematology Quality Control Class II
FDA product code JPK covers "Mixture, Hematology Quality Control", a Class II medical device regulated under 21 CFR 864.8625. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K160586 | streck | XN-L CHECK | December 22, 2016 |
| K160588 | streck | XN CHECK BF | December 22, 2016 |
| K160590 | streck | XN CHECK | December 22, 2016 |
| K160606 | r and d systems | BC-5D Hematology Control | September 1, 2016 |
| K141957 | streck | XN CHECK BF | December 5, 2014 |
| K141964 | streck | XN CHECK | 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 |