Atlas FDA

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100

FDA 510(k) clearance K023764 · decided 2003-01-28

Clearance details

K-number
K023764
Device name
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
Applicant
Beckman Coulter, Inc.
Decision
Substantially Equivalent
Date received
2002-11-12
Decision date
2003-01-28
Days to decision
77 days
Clearance type
Traditional
Product code
JJE
Device class
1
Regulation number
862.2160
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Chaska, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100 recall (Z-2266-2025)Beckman Coulter, Inc.2025-08-05
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 recall (Z-2267-2025)Beckman Coulter, Inc.2025-08-05
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456 recall (Z-2268-2025)Beckman Coulter, Inc.2025-08-05
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260 recall (Z-2269-2025)Beckman Coulter, Inc.2025-08-05
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 recall (Z-2270-2025)Beckman Coulter, Inc.2025-08-05
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460 recall (Z-2271-2025)Beckman Coulter, Inc.2025-08-05
Ringed DxI Reaction Vessels (RVs) recall (Z-2237-2023)Beckman Coulter, Inc.2023-07-26
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation recall (Z-1077-2019)Beckman Coulter Inc.2019-03-30
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the qua recall (Z-2687-2014)Beckman Coulter Inc.2014-09-23
UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in recall (Z-0985-2014)Beckman Coulter Inc.2014-02-16
UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The Un recall (Z-0345-2013)Beckman Coulter Inc.2012-11-19
UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The Un recall (Z-0346-2013)Beckman Coulter Inc.2012-11-19
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufa recall (Z-2257-2012)Beckman Coulter Inc.2012-08-23
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spo recall (Z-2258-2012)Beckman Coulter Inc.2012-08-23
UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i recall (Z-2259-2012)Beckman Coulter Inc.2012-08-23
UniCel DxI 800 Access Immunoassay Systems Part Numbers: 973100 UniCel DxI 600 Access Immun recall (Z-3127-2011)Beckman Coulter Inc.2012-01-30
Beckman Coulter UniCel DxI 800 Access Immunoassay System with Unicel DXI system software v recall (Z-2685-2011)Beckman Coulter Inc.2011-06-28
UniCel DxI 800 Access Immunoassay Systems; Part Number(s): DxI 800: 973100, DxI 800 Remanu recall (Z-1938-2011)Beckman Coulter Inc.2011-04-11
UniCel DxI 600 Access Immunoassay Systems; Part Number(s): DxI 600: A30260, DxI 600 with s recall (Z-1939-2011)Beckman Coulter Inc.2011-04-11
UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems; Part Number(s): DxC 66 recall (Z-1940-2011)Beckman Coulter Inc.2011-04-11
Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number recall (Z-0607-2011)Beckman Coulter Inc.2010-12-13
Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel Dx recall (Z-0914-2010)Beckman Coulter Inc.2010-03-02
UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i S recall (Z-0856-2010)Beckman Coulter Inc.2010-02-25
UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron Access Clinical Syst recall (Z-2387-2008)Beckman Coulter Inc2008-09-21
Beckman Coulter UniCel Dxl 800 Access Immunoassay System; Part Number: 973100 With: UniCel recall (Z-1184-2008)Beckman Coulter Inc2008-08-20
UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immu recall (Z-1108-2008)Beckman Coulter Inc2008-03-19
UniCel Dxl 800 Access Immunoassay Systems Wash Buffer, Part Number 8547197 Wash Buffer recall (Z-1518-06)Beckman Coulter Inc2006-09-23
UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier recall (Z-0583-06)Beckman Coulter Inc2006-03-03
UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels). recall (Z-0371-05)Beckman Coulter Inc2004-12-28
UniCel Dxl 800 Access Immunoassay System, P/N 973100. recall (Z-0904-04)Beckman Coulter Inc2004-07-20

PMA approvals by this applicant

RecordFirmDate
Access AFP (on DxI 9000 Analyzer) (P980041/S051)Beckman Coulter, Inc.2025-11-03
Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015)Beckman Coulter, Inc.2025-10-17
Access Hybritech p2PSA (P090026/S032)Beckman Coulter, Inc.2025-06-16
Access Hybritech free PSA (P970038/S046)Beckman Coulter, Inc.2025-05-15
Access Hybritech PSA (P850048/S060)Beckman Coulter, Inc.2024-09-04
Access Hybritech PSA reagent pack (P850048/S059)Beckman Coulter, Inc.2023-05-25
Access AFP Reagents on the Access Immunoassay Systems (P980041/S050)Beckman Coulter, Inc.2022-12-16
Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057)Beckman Coulter, Inc.2022-12-16