Atlas FDA

UREA

FDA 510(k) clearance K981918 · decided 1998-07-28

Clearance details

K-number
K981918
Device name
UREA
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1998-06-01
Decision date
1998-07-28
Days to decision
57 days
Clearance type
Traditional
Product code
CDQ
Device class
2
Regulation number
862.1770
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Irving, TX, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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Recalls involving this device

RecordFirmDate
Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation recall (Z-0189-2012)Abbott Laboratories, Inc2011-11-16

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