Atlas FDA

ABBOTT CELL-DYN 3200 SYSTEM

FDA 510(k) clearance K972354 · decided 1997-09-16

Clearance details

K-number
K972354
Device name
ABBOTT CELL-DYN 3200 SYSTEM
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1997-06-24
Decision date
1997-09-16
Days to decision
84 days
Clearance type
Traditional
Product code
GKZ
Device class
2
Regulation number
864.5220
Medical specialty
Hematology
Advisory committee
Hematology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CELL-DYN Shear Valve Assembly used on CELL-DYN 3200CS Analyzer and CELL-DYN 3200CS Analyze recall (Z-2017-2011)Abbott Laboratories2011-04-29
CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyze recall (Z-2018-2011)Abbott Laboratories2011-04-29
The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are compone recall (Z-1698-2011)Abbott Laboratories2011-03-17
Abbott CELL-DYN 3200 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3200 SL (Sample Loa recall (Z-1702-2011)Abbott Laboratories2011-03-17
CELL-DYN 3200 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Cl recall (Z-2350-2010)Abbott Laboratories2010-09-02
CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by recall (Z-0706-2007)Abbott Laboratories2007-04-03

PMA approvals by this applicant

RecordFirmDate
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
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30