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