Atlas FDA

AU5800(R) CHEMISTRY ANALYZER

FDA 510(k) clearance K112412 · decided 2011-12-23

Clearance details

K-number
K112412
Device name
AU5800(R) CHEMISTRY ANALYZER
Applicant
Beckman Coulter, Inc.
Decision
Substantially Equivalent
Date received
2011-08-22
Decision date
2011-12-23
Days to decision
123 days
Clearance type
Traditional
Product code
CEM
Device class
2
Regulation number
862.1600
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Brea, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The recall (Z-1704-2017)Beckman Coulter Inc.2017-04-03
AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical che recall (Z-2310-2016)Beckman Coulter Inc.2016-08-01
ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automa recall (Z-0153-2014)Beckman Coulter Inc.2013-11-05
Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemi recall (Z-1873-2013)Beckman Coulter Inc.2013-08-02
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions recall (Z-1834-2013)Beckman Coulter Inc.2013-07-31
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer recall (Z-1167-2013)Beckman Coulter Inc.2013-04-24
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that m recall (Z-0913-2013)Beckman Coulter Inc.2013-03-06

PMA approvals by this applicant

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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