Atlas FDA

ABBOTT AXSYM FOLATE

FDA 510(k) clearance K972232 · decided 1997-06-24

Clearance details

K-number
K972232
Device name
ABBOTT AXSYM FOLATE
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1997-06-16
Decision date
1997-06-24
Days to decision
8 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
AxSYM Folate Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM Folate is an recall (Z-1049-2009)Abbott Laboratories2009-04-15
AxSYM Folate Reagent Pack; list 03C81 ; 100 test pack; in-vitro diagnostic; Abbott Laborat recall (Z-1029-2007)Abbott Laboratories2007-07-11
AxSYM Folate Specimen Diluent, list 3C81-50, 10 mL bottles containing TRIS buffer with pro recall (Z-0365-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
AxSYM Folate RBC Protein Diluent Pack, list 3C81-65; one 13 mL bottle contains human album recall (Z-0366-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
AxSYM Folate Medium Control Pack , list 3C81-11, the pack contains 8 - 1 mL vials of Mediu recall (Z-0367-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
Folate Low and High Controls, list 9C13-10; the pack contains 8 - 2 mL bottles( 4 for each recall (Z-0368-04)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