FDA Product Code
FDA Product Code JPK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8625
510(k) Clearances — 192 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K160590 | XN CHECK | Streck | 2016-12-22 | Traditional | PDF ↗ |
| K160586 | XN-L CHECK | Streck | 2016-12-22 | Traditional | PDF ↗ |
| K160588 | XN CHECK BF | Streck | 2016-12-22 | Traditional | PDF ↗ |
| K160606 | BC-5D Hematology Control | R&D Systems, Inc. | 2016-09-01 | Traditional | PDF ↗ |
| K141957 | XN CHECK BF | Streck | 2014-12-05 | Traditional | PDF ↗ |
| K141964 | XN CHECK | Streck | 2014-12-05 | Traditional | PDF ↗ |
| K130962 | R&D 5D RETIC HEMATOLOGY CONTROL | R&D Systems, Inc. | 2013-07-24 | Special | PDF ↗ |
| K120742 | XN CHECK | Streck | 2012-10-19 | Traditional | PDF ↗ |
| K120744 | XN CHECK BF | Streck | 2012-10-19 | Traditional | PDF ↗ |
| K101578 | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL | R&D Systems, Inc. | 2011-04-28 | Traditional | PDF ↗ |
| K100790 | COULTER LIN-X LINEARITY CONTROL, MODEL A81196 | Beckman Coulter, Inc. | 2010-12-21 | Traditional | PDF ↗ |
| K100607 | COULTER 4C-EX 300 CELL CONTROL | Beckman Coulter, Inc. | 2010-11-18 | Traditional | PDF ↗ |
| K091303 | LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV | Bio-Rad Laboratories | 2010-08-02 | Traditional | PDF ↗ |
| K100050 | R & D SYSTEMS XERET HEMATOLOGY CONTROL | R&D Systems, Inc. | 2010-01-29 | Special | PDF ↗ |
| K091433 | R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL | R&D Systems, Inc. | 2009-10-28 | Special | PDF ↗ |
| K090201 | UA-CELLULAR FOR IQ | Streck | 2009-03-27 | Traditional | PDF ↗ |
| K082162 | COULTER BODY FLUID CONTROL | Beckman Coulter, Inc. | 2009-02-03 | Traditional | PDF ↗ |
| K081822 | COULTER 6C CELL CONTROL, MODELS 628027 & A59925 | Beckman Coulter, Inc. | 2009-01-21 | Traditional | PDF ↗ |
| K081641 | COULTER LIN-X LINEARITY CONTROL | Beckman Coulter, Inc. | 2009-01-16 | Traditional | PDF ↗ |
| K073178 | HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 | R&D Systems, Inc. | 2007-12-27 | Traditional | PDF ↗ |
| K072846 | CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 | R&D Systems, Inc. | 2007-11-26 | Traditional | PDF ↗ |
| K072268 | HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S | R&D Systems, Inc. | 2007-11-20 | Traditional | PDF ↗ |
| K072096 | CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 | R&D Systems, Inc. | 2007-08-20 | Special | PDF ↗ |
| K070199 | RETIC-CHEX LINEARITY FOR BC | Streck | 2007-02-23 | Traditional | PDF ↗ |
| K063218 | E-CHECK (XE) | Streck | 2006-12-14 | Traditional | PDF ↗ |
| K061511 | R&D CBC-3D + CRP HEMATOLOGY CONTROL | R&D Systems, Inc. | 2006-07-10 | Special | PDF ↗ |
| K061320 | R&D LH-NRBC HEMATOLOGY CONTROL | R&D Systems, Inc. | 2006-06-02 | Special | PDF ↗ |
| K061064 | COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503 | Beckman Coulter, Inc. | 2006-05-17 | Traditional | PDF ↗ |
| K060464 | COULTER 5C CELL CONTROL | Beckman Coulter, Inc. | 2006-03-28 | Traditional | PDF ↗ |
| K053362 | CELL-CHEX AUTO | Streck | 2006-01-13 | Traditional | PDF ↗ |
| K051706 | IQ BODY FLUIDS CONTROL | Streck | 2005-08-17 | Traditional | PDF ↗ |
| K051339 | R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL | R&D Systems, Inc. | 2005-07-12 | Special | PDF ↗ |
| K050721 | ABX ERYTROL | Horiba Abx | 2005-06-01 | Traditional | PDF ↗ |
| K042836 | LIQUICHEK RETICULOCYTE CONTROL (A) | Bio-Rad | 2004-11-05 | Traditional | PDF ↗ |
| K042587 | RETIC-CHEX FOR CELL-DYN | Streck Laboratories, Inc. | 2004-10-19 | Traditional | PDF ↗ |
| K042336 | METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK | Bio-Rad Laboratories, Inc. | 2004-10-14 | Traditional | PDF ↗ |
| K042094 | R&D CBC-XE HEMATOLOGY CONTROL | R&D Systems, Inc. | 2004-09-01 | Special | PDF ↗ |
| K041457 | LIQUICHEK HEMATOLOGY CONTROL (A) | Bio-Rad | 2004-06-28 | Traditional | PDF ↗ |
| K024173 | CDS 3-PD HEMATOLOGY CONTROLS | Clinical Diagnostic Solutions, Inc. | 2003-01-14 | Traditional | PDF ↗ |
| K022968 | ADVIA TESTPOINT CSF CONTROL | Bayer Diagnostics Corp. | 2002-09-24 | Traditional | PDF ↗ |
| K021922 | MODIFICATION TO PARA 5X | Streck Laboratories, Inc. | 2002-06-25 | Special | PDF ↗ |
| K020229 | R & D BODY FLUID CONTROL | R&D Systems, Inc. | 2002-02-06 | Traditional | PDF ↗ |
| K013898 | R&D RET-LINE KIT | R&D Systems, Inc. | 2002-01-22 | Traditional | PDF ↗ |
| K013842 | IMMUNO-TROL LOW CELLS | Beckman Coulter, Inc. | 2001-12-13 | Traditional | PDF ↗ |
| K011410 | PARA 5X | Streck Laboratories, Inc. | 2001-06-26 | Traditional | PDF ↗ |
| K010470 | R & D 4K RETIC | R&D Systems, Inc. | 2001-05-11 | Traditional | PDF ↗ |
| K010461 | ADVIA RETIC PLUS | R&D Systems, Inc. | 2001-04-03 | Traditional | PDF ↗ |
| K010598 | SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL | Quantimetrix Corp. | 2001-03-23 | Traditional | PDF ↗ |
| K010409 | CBC-SF | R&D Systems, Inc. | 2001-03-16 | Traditional | PDF ↗ |
| K010064 | 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 | Beckman Coulter, Inc. | 2001-02-07 | Special | PDF ↗ |
| K010066 | 5C-ES CELL CONTROL, MODELS 7547191, 7547192 | Beckman Coulter, Inc. | 2001-02-07 | Special | PDF ↗ |
| K003874 | CBC-4K HEMATOLOGY CONTROL | R&D Systems, Inc. | 2001-01-12 | Special | PDF ↗ |
| K003534 | PENTRA 5D | R&D Systems, Inc. | 2000-12-01 | Traditional | PDF ↗ |
| K003208 | R & D 3K RETIC | R&D Systems, Inc. | 2000-11-07 | Special | PDF ↗ |
| K002511 | FETALTROL | Trillium Diagnostics, LLC | 2000-09-11 | Traditional | PDF ↗ |
| K000115 | RETIC CHEX LINEARITY | Streck Laboratories, Inc. | 2000-03-27 | Traditional | PDF ↗ |
| K993496 | RETIC-QUINOX | Hematronix, Inc. | 1999-11-30 | Traditional | PDF ↗ |
| K991876 | SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE | R&D Systems, Inc. | 1999-06-17 | Traditional | PDF ↗ |
| K984216 | IMMUNO-TROL CONTROL CELLS | Coulter Corp. | 1999-03-16 | Traditional | PDF ↗ |
| K983032 | CBC-5D HEMATOLOGY CONTROL | R&D Systems, Inc. | 1999-02-17 | Traditional | PDF ↗ |
| K984099 | QBC CENTRIFUGAL HEMATOLOGY CONTROL | R&D Systems, Inc. | 1998-12-10 | Special | PDF ↗ |
| K972170 | ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION | R&D Systems, Inc. | 1997-07-24 | Traditional | PDF ↗ |
| K972172 | ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION | R&D Systems, Inc. | 1997-07-24 | Traditional | PDF ↗ |
| K971469 | COULTER ACT TRON CELL CONTROL | Coulter Corp. | 1997-06-30 | Traditional | PDF ↗ |
| K970331 | CBC-4K HEMATOLOGY CONTROL | R&D Systems, Inc. | 1997-04-16 | Traditional | PDF ↗ |
| K961673 | R&D RETIC-PG HEMATOLOGY CONTROL | R&D Systems, Inc. | 1996-07-15 | Traditional | PDF ↗ |
| K960557 | CALIBRATION VERIFICATION ASSESSMENT (CVA) | Streck Laboratories, Inc. | 1996-04-03 | Traditional | PDF ↗ |
| K960471 | TRI-COUNT 20 | Hematronix, Inc. | 1996-03-20 | Traditional | PDF ↗ |
| K960005 | TRI-COURT 20-T | Hematronix, Inc. | 1996-03-19 | Traditional | PDF ↗ |
| K955334 | COULTER LINEARITY CONTROL | Coulter Corp. | 1996-02-08 | Traditional | PDF ↗ |
| K955016 | 4C PLUS COULTER CELL CONTROL | Coulter Corp. | 1996-01-30 | Traditional | PDF ↗ |
| K954137 | QBC CENTRIFUGAL HEMATOLOGY CONTROL | R&D Systems, Inc. | 1995-10-06 | Traditional | PDF ↗ |
| K952720 | AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II | Aalto Scientific, Ltd. | 1995-09-20 | Traditional | PDF ↗ |
| K952245 | SF-CHECK | Streck Laboratories, Inc. | 1995-09-01 | Traditional | PDF ↗ |
| K941965 | EZ-RANGE | Hematronix, Inc. | 1995-04-25 | Traditional | PDF ↗ |
| K943336 | RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1994-12-12 | Traditional | PDF ↗ |
| K943335 | RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1994-12-12 | Traditional | PDF ↗ |
| K944751 | COULTER FLOW SET | Coulter Corp. | 1994-12-08 | Traditional | PDF ↗ |
| K942822 | CBC-LINE HEMATOLOGY LINEARITY CONTROL | R&D Systems, Inc. | 1994-10-07 | Traditional | PDF ↗ |
| K935196 | PARA 5 DIFF | Streck Laboratories, Inc. | 1994-04-05 | Traditional | PDF ↗ |
| K940089 | CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1994-03-22 | Traditional | PDF ↗ |
| K940181 | SE-CHECK | Streck Laboratories, Inc. | 1994-03-09 | Traditional | PDF ↗ |
| K935343 | CENTRIFIQ BLOOD CONTROL | Hematronix, Inc. | 1994-01-27 | Traditional | PDF ↗ |
| K931947 | CHECKPOINT | Medical Specialties, Inc. | 1993-06-18 | Traditional | PDF ↗ |
| K930119 | COULTER RETIC-C CELL CONTROL | Coulter Electronics, Inc. | 1993-04-05 | Traditional | PDF ↗ |
| K923971 | QC-CHEX | Streck Laboratories, Inc. | 1992-11-16 | Traditional | PDF ↗ |
| K914099 | GAS TRAK CONNECT BLOOD GAS CONTROL | Biochemical Sciences, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K913879 | CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1991-11-27 | Traditional | PDF ↗ |
| K912133 | PX COULTER(R) CELL CONTROL | Coulter Electronics, Inc. | 1991-07-17 | Traditional | PDF ↗ |
| K905524 | RETIC-CHEX | Streck Laboratories, Inc. | 1991-02-20 | Traditional | PDF ↗ |
| K904637 | QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1990-10-29 | Traditional | PDF ↗ |
| K904461 | METER TRAX | Hematronix, Inc. | 1990-10-26 | Traditional | PDF ↗ |
| K904464 | CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED | R&D Systems, Inc. | 1990-10-23 | Traditional | PDF ↗ |
| K900017 | REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210) | Helena Laboratories | 1990-01-29 | Traditional | PDF ↗ |
| K893895 | HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL | Intercare Diagnostics, Inc. | 1989-07-25 | Traditional | PDF ↗ |
| K884266 | PH BLOOD GAS CONTROL PRODUCTS | Alko Diagnostic Corp. | 1989-05-16 | Traditional | PDF ↗ |
| K890767 | NE-CHECK | Streck Laboratories, Inc. | 1989-03-23 | Traditional | PDF ↗ |
| K890749 | CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1989-02-27 | Traditional | PDF ↗ |
| K880270 | MSI-DIFF PLUS | Medical Specialties, Inc. | 1988-03-01 | Traditional | PDF ↗ |
| K873354 | QBC VENOUS BLOOD CONTROL/MULTIPLE | R&D Systems, Inc. | 1987-09-29 | Traditional | PDF ↗ |
Product code JPK · Class II · Hematology. Data: openFDA.