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FDA 510(k)

HemosIL Silica Clotting Time

K-Number: K160445 · 2016-03-16

ApplicantInstrumentation Laboratory CO
Decision Date2016-03-16
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HemosIL Silica Clotting Time 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 2016-03-16 under 510(k) number K160445. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemosIL Silica Clotting Time?

HemosIL Silica Clotting Time is a medical device that received FDA 510(k) clearance on 2016-03-16. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K160445.

When did HemosIL Silica Clotting Time receive FDA 510(k) clearance?

HemosIL Silica Clotting Time received FDA 510(k) clearance on 2016-03-16, under 510(k) number K160445.

Who is the listed applicant for HemosIL Silica Clotting Time?

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 Silica Clotting Time?

The FDA product code for HemosIL Silica Clotting Time is GFO.

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: GFO)

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.

K253957HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co.K193556Cryocheck Hex LAPrecision Biologic

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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