Atlas FDA

HEMOCCULT ICT

FDA 510(k) clearance K080812 · decided 2008-06-25

Clearance details

K-number
K080812
Device name
HEMOCCULT ICT
Applicant
Beckman Coulter, Inc.
Decision
Substantially Equivalent
Date received
2008-03-24
Decision date
2008-06-25
Days to decision
93 days
Clearance type
Traditional
Product code
KHE
Device class
2
Regulation number
864.6550
Medical specialty
Hematology
Advisory committee
Hematology
Location
Brea, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (T recall (Z-2197-2013)Assuramed2013-09-13
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitat recall (Z-1997-2013)Beckman Coulter Inc.2013-08-22

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