Atlas FDA

ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384

FDA 510(k) clearance K022203 · decided 2002-08-01

Clearance details

K-number
K022203
Device name
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2002-07-05
Decision date
2002-08-01
Days to decision
27 days
Clearance type
Special
Product code
MEA
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Recalls involving this device

RecordFirmDate
LifeCare PCA 3, list #s 12384-04-01, 12384-04-03, 12384-04-05, 12384-04-07, 12384-04-09, 1 recall (Z-0017-2010)Hospira Inc2009-10-06
Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09 recall (Z-0601-06)Hospira Inc2006-03-09

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