Atlas FDA

TETRACHROME REAGENTS AND TETRACXP SYSTEM

FDA 510(k) clearance K121445 · decided 2013-07-26

Clearance details

K-number
K121445
Device name
TETRACHROME REAGENTS AND TETRACXP SYSTEM
Applicant
Beckman Coulter, Inc.
Decision
Substantially Equivalent
Date received
2012-05-15
Decision date
2013-07-26
Days to decision
437 days
Clearance type
Special
Product code
OYE
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

No recalls on record reference this clearance.

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