Atlas FDA

AXSYM DIGOXIN II

FDA 510(k) clearance K953718 · decided 1995-09-25

Clearance details

K-number
K953718
Device name
AXSYM DIGOXIN II
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1995-08-09
Decision date
1995-09-25
Days to decision
47 days
Clearance type
Traditional
Product code
KXT
Device class
2
Regulation number
862.3320
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 (K082953)Biokit, S.A.2008-12-22
AXSYM DIGOXIN III (K061249)Abbott Laboratories2006-06-02
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM (K033007)Bayer Diagnostics Corp.2003-11-14
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM (K023058)Seradyn2002-10-24
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) (K012301)Diagnostic Products Corp.2001-09-19
RANDOX DIGOXIN (K011302)Randox Laboratories, Ltd.2001-07-02
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 (K011920)Syva Co., Dade Behring, Inc.2001-07-02
DIGOXIN IMMUNOASSAY (K983323)Diagnostic Reagents, Inc.1998-11-12

Recalls involving this device

RecordFirmDate
AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02) The AxSYM Digoxin II a recall (Z-0297-2009)Abbott Diagnostic International, Ltd.2008-11-21

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