KQJ

System, Fibrinogen Determination

Product code
KQJ
Device name
System, Fibrinogen Determination
Device class
Class 2
21 CFR
21 CFR 864.7340
Medical specialty
Hematology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
28 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-07-24.

NumberDecision dateApplicantDevice nameSummary
K2519682025-07-24Instrumentation Laboratory (IL) Co.HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLPDF

1 summaries are archived here for direct download.

Official FDA classification page: KQJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).