Atlas FDA

MULTICONSTITUENT CALIBRATOR

FDA 510(k) clearance K103403 · decided 2011-02-04

Clearance details

K-number
K103403
Device name
MULTICONSTITUENT CALIBRATOR
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2010-11-19
Decision date
2011-02-04
Days to decision
77 days
Clearance type
Traditional
Product code
JIX
Device class
2
Regulation number
862.1150
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

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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