Atlas FDA

ABBOTT AXSYM MYOGLOBIN

FDA 510(k) clearance K983848 · decided 1998-11-16

Clearance details

K-number
K983848
Device name
ABBOTT AXSYM MYOGLOBIN
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1998-10-30
Decision date
1998-11-16
Days to decision
17 days
Clearance type
Traditional
Product code
DDR
Device class
2
Regulation number
866.5680
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 Myoglobin Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM Myoglobin recall (Z-1050-2009)Abbott Laboratories2009-04-15
AxSYM Myoglobin Reagent Pack; list 03E43; 100 test pack; in-vitro diagnostic; Abbott Labor recall (Z-1030-2007)Abbott Laboratories2007-07-11

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