Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HemosIL ReadiPlasTin

K-Number: K213426 · 2022-08-16

ApplicantInstrumentation Laboratory CO
Decision Date2022-08-16
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HemosIL ReadiPlasTin is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2022-08-16 under 510(k) number K213426. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemosIL ReadiPlasTin?

HemosIL ReadiPlasTin is a medical device that received FDA 510(k) clearance on 2022-08-16. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K213426.

When did HemosIL ReadiPlasTin receive FDA 510(k) clearance?

HemosIL ReadiPlasTin received FDA 510(k) clearance on 2022-08-16, under 510(k) number K213426.

Who is the listed applicant for HemosIL ReadiPlasTin?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HemosIL ReadiPlasTin?

The FDA product code for HemosIL ReadiPlasTin is GJS.

Other records listing Instrumentation Laboratory CO as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233790ACL TOP 970 CLK230852HemosIL Chromogenic Factor IXK221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223608GEM Premier 7000 with IQM3K223187HemosIL Liquid Anti-XaK231031ACL TOP Family 70 Series

View all 29 devices →

Related Devices (Code: GJS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253188CoaguChek XS Plus SystemRoche DiagnosticsK251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott LaboratoriesK231711microINR SystemIline Microsystems, S.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑