Atlas FDA

MODIFICATION TO ALKP

FDA 510(k) clearance K023807 · decided 2002-12-26

Clearance details

K-number
K023807
Device name
MODIFICATION TO ALKP
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2002-11-14
Decision date
2002-12-26
Days to decision
42 days
Clearance type
Special
Product code
CJE
Device class
2
Regulation number
862.1050
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Irving, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
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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