| MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) (K014034) | Beckman Coulter, Inc. | 2001-12-18 |
| IMMUNO-TROL LOW CELLS (K013842) | Beckman Coulter, Inc. | 2001-12-13 |
| SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR (K013076) | Beckman Coulter, Inc. | 2001-12-12 |
| ACCESS UNCONJUGATED ESTRIOL CALIBRATORS (K012900) | Beckman Coulter, Inc. | 2001-10-16 |
| MODIFICATION TO SYNCHRON CONTROL (K013235) | Beckman Coulter, Inc. | 2001-10-16 |
| ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 (K012208) | Beckman Coulter, Inc. | 2001-09-07 |
| SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT (K010748) | Beckman Coulter, Inc. | 2001-07-10 |
| COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 (K011342) | Beckman Coulter, Inc. | 2001-07-09 |
| ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479 (K003259) | Beckman Coulter, Inc. | 2001-06-13 |
| SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO (K011465) | Beckman Coulter, Inc. | 2001-06-08 |
| ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345 (K010429) | Beckman Coulter, Inc. | 2001-06-05 |
| SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT (K010597) | Beckman Coulter, Inc. | 2001-05-29 |
| MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM (K011213) | Beckman Coulter, Inc. | 2001-05-16 |
| BECKMAN COULTER DNASE B CALIBRATOR (K010696) | Beckman Coulter, Inc. | 2001-05-10 |
| COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 (K010765) | Beckman Coulter, Inc. | 2001-04-13 |
| VIGIL DNASE B CONTROL (K010693) | Beckman Coulter, Inc. | 2001-04-11 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT (K010236) | Beckman Coulter, Inc. | 2001-04-05 |
| ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 (K010428) | Beckman Coulter, Inc. | 2001-03-13 |
| VIGIL SEROLOGY CONTROL LEVEL C (K010358) | Beckman Coulter, Inc. | 2001-03-05 |
| 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 |
| SYNCHRON SYSTEMS AMMONIA REAGENT (K003196) | Beckman Coulter, Inc. | 2000-12-22 |
| SYNCHRON CONTROL (K003488) | Beckman Coulter, Inc. | 2000-11-27 |
| ACCESS ULTRASENSITIVE HGH CALIBRATORS (K003098) | Beckman Coulter, Inc. | 2000-11-20 |
| ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER (K002905) | Beckman Coulter, Inc. | 2000-10-19 |
| PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 (K002799) | Beckman Coulter, Inc. | 2000-10-05 |
| ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479 (K002453) | Beckman Coulter, Inc. | 2000-08-31 |
| ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565 (K001935) | Beckman Coulter, Inc. | 2000-08-22 |
| SYNCHRON CONTROL (K001458) | Beckman Coulter, Inc. | 2000-06-02 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB (K000121) | Beckman Coulter, Inc. | 2000-05-17 |
| SYNCHRON SYSTEMS AMPHETAMINE REAGENT (K000606) | Beckman Coulter, Inc. | 2000-05-05 |
| SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT (K000494) | Beckman Coulter, Inc. | 2000-04-14 |
| SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS (K000410) | Beckman Coulter, Inc. | 2000-04-10 |
| ACCESS OSTASE IMMUNOENZYMETRIC ASSAY (K994278) | Beckman Coulter, Inc. | 2000-03-28 |
| ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER (K000716) | Beckman Coulter, Inc. | 2000-03-20 |
| ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 (K000196) | Beckman Coulter, Inc. | 2000-02-18 |
| SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR (K000331) | Beckman Coulter, Inc. | 2000-02-10 |
| SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR (K994168) | Beckman Coulter, Inc. | 2000-02-03 |
| SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR (K994169) | Beckman Coulter, Inc. | 2000-02-03 |
| BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR (K993549) | Beckman Coulter, Inc. | 2000-02-01 |
| BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB (K993547) | Beckman Coulter, Inc. | 2000-02-01 |
| ACCESS HYBRITECH PSA QC, MODEL 37209 (K994200) | Beckman Coulter, Inc. | 2000-01-18 |
| ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306 (K994439) | Beckman Coulter, Inc. | 2000-01-14 |
| ACCESS OSTASE QC (K994277) | Beckman Coulter, Inc. | 2000-01-14 |
| SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR (K994325) | Beckman Coulter, Inc. | 2000-01-12 |
| SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS (K993954) | Beckman Coulter, Inc. | 2000-01-11 |
| ACCESS HYBRITECH FREE PSA QC, MODEL 37219 (K993210) | Beckman Coulter, Inc. | 2000-01-05 |
| SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS (K993023) | Beckman Coulter, Inc. | 1999-11-26 |
| SYNCHRON SYSTEMS DRUG CALIBRATOR 2 (K993473) | Beckman Coulter, Inc. | 1999-11-26 |
| SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS (K993022) | Beckman Coulter, Inc. | 1999-11-09 |
| ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT (K990704) | Beckman Coulter, Inc. | 1999-05-03 |
| SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT (K984402) | Beckman Coulter, Inc. | 1999-01-29 |
| SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT (K984152) | Beckman Coulter, Inc. | 1999-01-29 |
| SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II (K983747) | Beckman Coulter, Inc. | 1998-12-30 |
| SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 (K984014) | Beckman Coulter, Inc. | 1998-12-23 |
| SYNCHRON SYSTEMS LIPID CALIBRATOR (K983640) | Beckman Coulter, Inc. | 1998-12-21 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR (K983340) | Beckman Coulter, Inc. | 1998-12-14 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT (K983895) | Beckman Coulter, Inc. | 1998-11-25 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT (K983151) | Beckman Coulter, Inc. | 1998-11-05 |
| SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I (K983209) | Beckman Coulter, Inc. | 1998-11-04 |
| SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 (K983709) | Beckman Coulter, Inc. | 1998-10-28 |
| SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR (K982935) | Beckman Coulter, Inc. | 1998-10-14 |
| ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 (K981985) | Beckman Coulter, Inc. | 1998-09-24 |
| VIGIL PROTEIN CONTROL (K982224) | Beckman Coulter, Inc. | 1998-07-09 |
| VIGIL HEMOGLOBIN (HBALC) CONTROLS (K982022) | Beckman Coulter, Inc. | 1998-07-06 |
| ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219 (K981864) | Beckman Coulter, Inc. | 1998-06-12 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT (K981638) | Beckman Coulter, Inc. | 1998-06-12 |
| ACCESS FOLATE ASSAY (MODIFICATION) (K955434) | Beckman Coulter, Inc. | 1996-01-29 |
| ACCESS RED BLOOD CELL FOLATE ASSAY (K943149) | Beckman Coulter, Inc. | 1994-08-26 |
| ACCESS FOLATE ASSAY (K932887) | Beckman Coulter, Inc. | 1993-10-12 |