Beckman Instruments, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 281
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K973448 | ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 | September 17, 1998 |
| K982250 | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | July 14, 1998 |
| K981403 | IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT | May 8, 1998 |
| K981354 | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 | May 1, 1998 |
| K980173 | ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 | March 18, 1998 |
| K974816 | ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 | February 20, 1998 |
| K974564 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT | February 17, 1998 |
| K974110 | IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT | December 24, 1997 |
| K974452 | VIGIL LIPID CONTROL | December 17, 1997 |
| K973932 | BECKMAN CALIBRATOR 2 (CAL2) | December 15, 1997 |
| K973928 | BECKMAN URINE PROTEIN CALIBRATOR (UCAL) | December 1, 1997 |
| K974050 | SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT | November 24, 1997 |
| K973696 | SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT | November 24, 1997 |
| K973813 | IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT | November 20, 1997 |
| K974075 | ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | November 10, 1997 |
| K973743 | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | October 31, 1997 |
| K973966 | ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | October 31, 1997 |
| K973069 | SYNCHRON SYSTEMS METHADONE REAGENT | September 22, 1997 |
| K971958 | SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT | August 20, 1997 |
| K972819 | VIGIL TDM CONTROLS | August 13, 1997 |