Product code JPK
- Device name
- Mixture, Hematology Quality Control
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.8625
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K160590 | XN CHECK | Streck | 2016-12-22 |
| K160588 | XN CHECK BF | Streck | 2016-12-22 |
| K160586 | XN-L CHECK | Streck | 2016-12-22 |
| K160606 | BC-5D Hematology Control | R&D Systems, Inc. | 2016-09-01 |
| K141964 | XN CHECK | Streck | 2014-12-05 |
| K141957 | XN CHECK BF | Streck | 2014-12-05 |
| K130962 | R&D 5D RETIC HEMATOLOGY CONTROL | R&D Systems, Inc. | 2013-07-24 |
| K120744 | XN CHECK BF | Streck | 2012-10-19 |
| K120742 | XN CHECK | Streck | 2012-10-19 |
| K101578 | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL | R&D Systems, Inc. | 2011-04-28 |
| K100790 | COULTER LIN-X LINEARITY CONTROL, MODEL A81196 | Beckman Coulter, Inc. | 2010-12-21 |
| K100607 | COULTER 4C-EX 300 CELL CONTROL | Beckman Coulter, Inc. | 2010-11-18 |
| K091303 | LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV | Bio-Rad Laboratories | 2010-08-02 |
| K100050 | R & D SYSTEMS XERET HEMATOLOGY CONTROL | R&D Systems, Inc. | 2010-01-29 |
| K091433 | R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL | R&D Systems, Inc. | 2009-10-28 |
| K090201 | UA-CELLULAR FOR IQ | Streck | 2009-03-27 |
| K082162 | COULTER BODY FLUID CONTROL | Beckman Coulter, Inc. | 2009-02-03 |
| K081822 | COULTER 6C CELL CONTROL, MODELS 628027 & A59925 | Beckman Coulter, Inc. | 2009-01-21 |
| K081641 | COULTER LIN-X LINEARITY CONTROL | Beckman Coulter, Inc. | 2009-01-16 |
| K073178 | HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 | R&D Systems, Inc. | 2007-12-27 |
| K072846 | CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 | R&D Systems, Inc. | 2007-11-26 |
| K072268 | HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S | R&D Systems, Inc. | 2007-11-20 |
| K072096 | CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 | R&D Systems, Inc. | 2007-08-20 |
| K070199 | RETIC-CHEX LINEARITY FOR BC | Streck | 2007-02-23 |
| K063218 | E-CHECK (XE) | Streck | 2006-12-14 |
| K061511 | R&D CBC-3D + CRP HEMATOLOGY CONTROL | R&D Systems, Inc. | 2006-07-10 |
| K061320 | R&D LH-NRBC HEMATOLOGY CONTROL | R&D Systems, Inc. | 2006-06-02 |
| K061064 | COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503 | Beckman Coulter, Inc. | 2006-05-17 |
| K060464 | COULTER 5C CELL CONTROL | Beckman Coulter, Inc. | 2006-03-28 |
| K053362 | CELL-CHEX AUTO | Streck | 2006-01-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00382906643438 | BD Trucountâ„¢ | Becton, Dickinson And Company | 2023-08-07 |
| 00816068020856 | Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit | Advanced Instruments, LLC | 2020-07-21 |
| 10815762020091 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-12-20 |
| 10815762020190 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-12-20 |
| 00816068020238 | Advanced Instruments GloCyte® Controls Kit | Advanced Instruments, LLC | 2016-09-23 |
| 15099590225865 | AQUIOS IMMUNO-TROL Low Cells | BECKMAN COULTER IRELAND INC. | 2016-09-23 |
| 15099590225759 | AQUIOS IMMUNO-TROL Cells | BECKMAN COULTER IRELAND INC. | 2016-09-23 |
| 00385480142441 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480141826 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480175142 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480170932 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480170925 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480142533 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480127042 | NOVA/STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480112727 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480095839 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 14987562460578 | e-CHECK(XS) | SYSMEX CORPORATION | 2016-08-05 |
| 10815762021753 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-08-03 |
| 10815762021746 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-08-03 |
| 10815762021739 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-08-03 |
| 10815762021371 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762021357 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762021098 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762021081 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762020862 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762020763 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762020442 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762020435 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762020343 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762020251 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |