Atlas FDA

SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO

FDA 510(k) clearance K011465 · decided 2001-06-08

Clearance details

K-number
K011465
Device name
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
Applicant
Beckman Coulter, Inc.
Decision
Substantially Equivalent
Date received
2001-05-14
Decision date
2001-06-08
Days to decision
25 days
Clearance type
Special
Product code
LDP
Device class
2
Regulation number
862.3030
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Brea, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Synchron CX4, CX5 and CX9 Pro Systems. recall (Z-0067-04)Beckman Coulter Inc2003-10-24

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