Cleared Traditional

HemosIL Chromogenic Factor IX

K230852 · Instrumentation Laboratory Company · Hematology

Dec 2023

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K230852 is an FDA 510(k) clearance for the HemosIL Chromogenic Factor IX, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Instrumentation Laboratory Company (Bedford, US). The FDA issued a Cleared decision on December 13, 2023, 260 days after receiving the submission on March 28, 2023. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number	K230852 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2023
Decision Date	December 13, 2023
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF