510(k) clearances

microINR System

Iline Microsystems, S.L. · Hematology

K243543Substantially EquivalentTraditionalGJS
Open FDA's page for this record
Third party flag
N
City
San Sebastian-Donostia
Advisory committee description
Hematology
Address 1
Paseo Mikeletegi 69
Statement or summary
Summary
Product code
GJS
Zip code
20009
Applicant
Iline Microsystems, S.L.
Decision date
2025-02-27
Decision code
SESE
Country code
ES
Device name
microINR System
Advisory committee
HE
Contact
Miren Itsaso Hormaeche
K number
K243543
Date received
2024-11-15
Review advisory committee
HE
Postal code
20009
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Test, Time, Prothrombin
Medical specialty description
Hematology
Regulation number
864.7750
Device class
2
Registration number
2085064, 3037000637, 3013298431, 2432235, 9710666, 3005146313, 3008386529, 3002721930, 9610806, 3006198300, 3012302888, 3010285483, 2245578, 8043723, 3015499222, 1835316, 3030186688, 1181121, 3003691680, 1618982, 3025915415, 2245451, 1217183, 3013188547, 9610126, 3011689956, 3013660430, 3007507465, 1219029, 3033967997, 1832816, 3005643513, 2431530
FEI number
3037000637, 3013298431, 2432235, 3005146313, 3008386529, 3006198300, 3003565434, 3012302888, 3010285483, 3002806559, 3001644026, 2245578, 3001573851, 3015499222, 3030186688, 3000210416, 1181121, 3003691680, 1618982, 1000135102, 2250033, 3025915415, 2245451, 1217183, 3013188547, 3011689956, 3013660430, 3007507465, 1219029, 3033967997, 1832816, 3005643513, 2431530
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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.