Atlas FDA

AXSYM CA 125

FDA 510(k) clearance K964020 · decided 1997-11-04

Clearance details

K-number
K964020
Device name
AXSYM CA 125
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1996-10-07
Decision date
1997-11-04
Days to decision
393 days
Clearance type
Traditional
Product code
LTK
Device class
2
Regulation number
866.6010
Medical specialty
Immunology
Advisory committee
Immunology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
AxSYM CA 125 Reagent Pack; list 03B41; 100 test pack; an in vitro diagnostic; Abbott Labor recall (Z-1026-2007)Abbott Laboratories2007-07-11
AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100 tes recall (Z-0318-04)Abbott Laboratories HPD/ADD/GPRD2004-01-10
CA 125 Calibrators, list 9C22-01; Abbott Laboratories, Abbott Park, IL 60064 recall (Z-0320-04)Abbott Laboratories HPD/ADD/GPRD2004-01-10
AxSYM CA 125 Master Calibrators, list 3B41-30; Abbott Laboratories, Abbott Park, IL 60064 recall (Z-0321-04)Abbott Laboratories HPD/ADD/GPRD2004-01-10

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