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FDA 510(k)

HemosIL Liquid Anti-Xa

K-Number: K223187 · 2023-06-23

ApplicantInstrumentation Laboratory CO
Decision Date2023-06-23
Product CodeQLU
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HemosIL Liquid Anti-Xa 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 2023-06-23 under 510(k) number K223187. The device is classified under product code QLU. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemosIL Liquid Anti-Xa?

HemosIL Liquid Anti-Xa is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K223187.

When did HemosIL Liquid Anti-Xa receive FDA 510(k) clearance?

HemosIL Liquid Anti-Xa received FDA 510(k) clearance on 2023-06-23, under 510(k) number K223187.

Who is the listed applicant for HemosIL Liquid Anti-Xa?

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 Liquid Anti-Xa?

The FDA product code for HemosIL Liquid Anti-Xa is QLU.

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 IQM3K231031ACL TOP Family 70 SeriesK223090GEM Premier ChemSTAT

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Related Devices (Code: QLU)

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.

K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)Siemens Healthcare Diagnostics Products GmbH

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.

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