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FDA 510(k)

HemosIL D-Dimer HS

K-Number: K160885 · 2016-10-27

ApplicantInstrumentation Laboratory CO
Decision Date2016-10-27
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HemosIL D-Dimer HS 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 2016-10-27 under 510(k) number K160885. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemosIL D-Dimer HS?

HemosIL D-Dimer HS is a medical device that received FDA 510(k) clearance on 2016-10-27. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K160885.

When did HemosIL D-Dimer HS receive FDA 510(k) clearance?

HemosIL D-Dimer HS received FDA 510(k) clearance on 2016-10-27, under 510(k) number K160885.

Who is the listed applicant for HemosIL D-Dimer HS?

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 D-Dimer HS?

The FDA product code for HemosIL D-Dimer HS is DAP.

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

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Related Devices (Code: DAP)

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.

K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)Siemens Healthcare Diagnostic Products GmbHK172903HemosIL D-Dimer HS 500Instrumentation Laboratory COK162227STA® - Liatest® D-DiDiagnostica Stago

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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