HemosIL ReadiPlasTin— 510(k) K213426

Name: FDA 510(k) clearance K213426
Creator: U.S. Food and Drug Administration
Published: 2022-08-16

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K213426 for HemosIL ReadiPlasTin, Substantially Equivalent on 2022-08-16. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GJS
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 2021-10-21
Decision date: 2022-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM2023-09-29
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K223090 — GEM Premier ChemSTAT2023-01-27
K223402 — HemosIL von Willebrand Factor Antigen2022-12-09
K213464 — HemosIL Liquid Anti-Xa2022-10-04

Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.