Atlas FDA

CELL-DYN SAPPHIRE SYSTEM

FDA 510(k) clearance K051215 · decided 2005-07-21

Clearance details

K-number
K051215
Device name
CELL-DYN SAPPHIRE SYSTEM
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2005-05-12
Decision date
2005-07-21
Days to decision
70 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 CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, M recall (Z-0604-2024)Abbott Laboratories2023-12-21
CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor) u recall (Z-2421-2010)Abbott Laboratories2010-09-14
CELL-DYN Sapphire, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, C recall (Z-2353-2010)Abbott Laboratories2010-09-02
Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated recall (Z-1069-2009)Abbott Laboratories2009-04-23
CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 A multi- parameter, recall (Z-0306-2009)Abbott Laboratories2008-11-21
CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface Spe recall (Z-2139-2008)Abbott Laboratories2008-08-21
White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Sy recall (Z-1103-2008)Abbott Laboratories2008-05-14
CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Ana recall (Z-1165-2008)Abbott Laboratories2008-04-24
Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H recall (Z-0301-2008)Abbott Laboratories2008-01-04
CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01, Distributed recall (Z-0708-2007)Abbott Laboratories2007-04-03
CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. Li recall (Z-0565-2007)Abbott Laboratories2007-03-01

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