Atlas FDA

UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

FDA 510(k) clearance K081930 · decided 2008-12-19

Clearance details

K-number
K081930
Device name
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
Applicant
Beckman Coulter, Inc.
Decision
Substantially Equivalent
Date received
2008-07-07
Decision date
2008-12-19
Days to decision
165 days
Clearance type
Abbreviated
Product code
GKZ
Device class
2
Regulation number
864.5220
Medical specialty
Hematology
Advisory committee
Hematology
Location
Miami, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B6830 recall (Z-1013-2017)Beckman Coulter Inc.2017-01-11
DxH 600 Coulter Cellular Analysis System, Catalog No. B23858 recall (Z-1014-2017)Beckman Coulter Inc.2017-01-11
UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029 recall (Z-0432-2016)Beckman Coulter Inc.2015-12-16
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 recall (Z-0433-2016)Beckman Coulter Inc.2015-12-16
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 recall (Z-0434-2016)Beckman Coulter Inc.2015-12-16
COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered recall (Z-1616-2015)Beckman Coulter Inc.2015-05-15
UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used recall (Z-1828-2014)Beckman Coulter Inc.2014-06-20
UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagno recall (Z-1829-2014)Beckman Coulter Inc.2014-06-20
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 an recall (Z-0147-2014)Beckman Coulter Inc.2013-11-04
Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 An recall (Z-0021-2013)Beckman Coulter Inc.2012-10-09
Unicel DxH 800 Coulter Cellular Analysis System Product Usage: UniCel DxH 800 Coulter Cell recall (Z-3125-2011)Beckman Coulter Inc.2011-09-01
Unicel DxH 800 Coulter Cellular Analysis System. A quantitative, automated hematology anal recall (Z-2227-2011)Beckman Coulter Inc.2011-05-20
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 An recall (Z-2172-2011)Beckman Coulter Inc.2011-05-10
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 An recall (Z-2157-2011)Beckman Coulter Inc.2011-05-09
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. The UniCel DxH 800 A recall (Z-2145-2011)Beckman Coulter Inc.2011-05-05
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 An recall (Z-2148-2011)Beckman Coulter Inc.2011-05-05
UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Ana recall (Z-2128-2011)Beckman Coulter Inc.2011-05-02
UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Ana recall (Z-2114-2011)Beckman Coulter Inc.2011-04-29
UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Ana recall (Z-2121-2011)Beckman Coulter Inc.2011-04-29
UniCel DxH 800 Floor Cabinet Part Number: 723335 The UniCel DxH 800 Analyzer is a quantita recall (Z-1980-2011)Beckman Coulter Inc.2011-04-14
UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Ana recall (Z-1977-2011)Beckman Coulter Inc.2011-04-13
UniCel DxH 800 Floor Cabinet Part Number: 723335 The UniCel DxH 800 Analyzer is a quantita recall (Z-1978-2011)Beckman Coulter Inc.2011-04-13
Unicel DxH 800 Coulter Cellular Analysis System recall (Z-2338-2010)Beckman Coulter Inc.2010-09-01
Unicel DxH 800 Coulter Cellular Analysis System, Part number(s): 629029 recall (Z-1905-2010)Beckman Coulter Inc.2010-06-25
UniCel DxH 800 Coulter Cellular Analysis System, Part Number 629029. Beckman Coulter, Inc. recall (Z-1656-2010)Beckman Coulter Inc.2010-05-26
Unicel DxH 800 Coulter Cellular Analysis System. Beckman Coulter, Inc. Brea, CA. Quantitat recall (Z-1658-2010)Beckman Coulter Inc.2010-05-26
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc recall (Z-1680-2010)Beckman Coulter Inc.2010-05-26

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