Atlas FDA

IMX CA 15-3

FDA 510(k) clearance K964407 · decided 1997-11-10

Clearance details

K-number
K964407
Device name
IMX CA 15-3
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1996-11-04
Decision date
1997-11-10
Days to decision
371 days
Clearance type
Traditional
Product code
MOI
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
CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15 recall (Z-1244-06)Abbott Laboratories MPG2006-07-18
CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactiv recall (Z-0680-03)Abbott Laboratories HPD/ADD2003-03-26
IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode recall (Z-0681-03)Abbott Laboratories HPD/ADD2003-03-26

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