Atlas FDA

ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)

FDA 510(k) clearance K971152 · decided 1997-08-12

Clearance details

K-number
K971152
Device name
ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1997-03-28
Decision date
1997-08-12
Days to decision
137 days
Clearance type
Traditional
Product code
GKZ
Device class
2
Regulation number
864.5220
Medical specialty
Hematology
Advisory committee
Hematology
Location
Santa Clara, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73 recall (Z-0648-03)Abbott Laboratories2003-03-13

PMA approvals by this applicant

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ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S032)Abbott Laboratories2026-05-11
ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92) (P910007/S068)Abbott Laboratories2026-02-23
ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93) (P980007/S056)Abbott Laboratories2026-02-12
ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92) (P910007/S067)Abbott Laboratories2026-02-12
ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S031)Abbott Laboratories2026-02-12
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03