Atlas FDA

ABBOTT ARCHITECT FOLATE

FDA 510(k) clearance K023397 · decided 2002-12-16

Clearance details

K-number
K023397
Device name
ABBOTT ARCHITECT FOLATE
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2002-10-09
Decision date
2002-12-16
Days to decision
68 days
Clearance type
Traditional
Product code
CGN
Device class
2
Regulation number
862.1295
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
ARCHITECT Folate Low and Medium Controls, List 6C12-10; the kit contains 2 - 8 mL vials, L recall (Z-0361-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
ARCHITECT Folate High Controls, List 6C12-11; the kit contains 8 - 1 mL vials of High Cont recall (Z-0362-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
ARCHITECT Folate Manual Diluent, List 6C12-50; One 4 mL bottle of ARCHITECT Folate Manual recall (Z-0363-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) recall (Z-0364-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20

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