FDA 510(k) Applications Submitted by MARY BETH TANG
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090588 |
03/04/2009 |
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 |
BECKMAN COULTER, INC. |
| K011465 |
05/14/2001 |
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO |
BECKMAN COULTER, INC. |
| K040181 |
01/27/2004 |
ACCESS DHEA-S REAGENT ASSAY |
BECKMAN COULTER, INC. |
| K060256 |
02/01/2006 |
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM |
BECKMAN COULTER, INC. |
| K010748 |
03/13/2001 |
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT |
BECKMAN COULTER, INC. |
| K021572 |
05/14/2002 |
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR |
BECKMAN COULTER, INC. |
| K031870 |
06/17/2003 |
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT |
BECKMAN COULTER, INC. |
| K041643 |
06/17/2004 |
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT |
BECKMAN COULTER, INC. |
| K242190 |
07/25/2024 |
Access Cortisol; DxC 500i Clinical Analyzer |
Beckman Coulter, Inc. |
| K042291 |
08/24/2004 |
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS |
BECKMAN COULTER, INC. |
| K023049 |
09/12/2002 |
SYNCHRON LX I 725 CLINICAL SYSTEM |
BECKMAN COULTER, INC. |
| K013076 |
09/14/2001 |
SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR |
BECKMAN COULTER, INC. |
| K242870 |
09/23/2024 |
Access hsTnI |
Beckman Coulter, Inc. |
| K013235 |
09/28/2001 |
MODIFICATION TO SYNCHRON CONTROL |
BECKMAN COULTER, INC. |
| K013978 |
12/03/2001 |
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT |
BECKMAN COULTER, INC. |
| K014103 |
12/13/2001 |
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR |
BECKMAN COULTER, INC. |
| K014173 |
12/20/2001 |
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR |
BECKMAN COULTER, INC. |
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