510(k) clearances

Calcium2

Abbott Ireland · Clinical Chemistry

K244042Substantially EquivalentTraditionalCJY
Open FDA's page for this record
Third party flag
N
City
Lisnamuck
Advisory committee description
Clinical Chemistry
Address 1
Diagnostic Divison
Statement or summary
Summary
Product code
CJY
Applicant
Abbott Ireland
Decision date
2025-02-10
Decision code
SESE
Country code
IE
Device name
Calcium2
Advisory committee
CH
Contact
Cherie Lipowsky
K number
K244042
Date received
2024-12-30
Review advisory committee
CH
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Azo Dye, Calcium
Medical specialty description
Clinical Chemistry
Regulation number
862.1145
Device class
2
Registration number
2085064, 3002642396, 2432235, 1220972, 3006716639, 2250051, 1319681, 3007662974, 3000148879, 2939693, 2050012, 1319809, 9680746, 2032112, 3012963943, 1181121, 2030861, 3003593973, 3000308930, 1319808, 3005333358, 3004493545, 8020316, 3016438761, 2247288, 8040374, 1616487, 3011989923, 2050010
FEI number
1000305840, 3002642396, 1000305841, 1220972, 3006716639, 2250051, 2432235, 3007662974, 3000148879, 1000122044, 3002806809, 1000206808, 2939693, 2050012, 1000136573, 3012963943, 5864, 1181121, 3003593973, 3000308930, 3005333358, 1000135102, 3004493545, 3000215862, 3016438761, 3003076831, 1616487, 3011989923, 2050010
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.