Atlas FDA

ABBOTT AXSYM SYSTEM

FDA 510(k) clearance K974651 · decided 1998-02-12

Clearance details

K-number
K974651
Device name
ABBOTT AXSYM SYSTEM
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1997-12-08
Decision date
1998-02-12
Days to decision
66 days
Clearance type
Traditional
Product code
JJE
Device class
1
Regulation number
862.2160
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories, Diagnost recall (Z-2317-2009)Abbott Laboratories2009-09-30
Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100 recall (Z-0117-2007)Abbott Diagnostic International, Ltd.2006-11-17
AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Tex recall (Z-0173-04)Abbott Laboratories, Inc2004-07-20
The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving recall (Z-0274-04)Abbott Laboratories, Inc2003-12-25
AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03 recall (Z-0421-03)Abbott Laboratories, Inc2003-01-11

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