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FDA 510(k)

HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls

K-Number: K153137 · 2016-07-08

ApplicantInstrumentation Laboratory CO
Decision Date2016-07-08
Product CodeLCO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls 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 2016-07-08 under 510(k) number K153137. The device is classified under product code LCO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls?

HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K153137.

When did HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls receive FDA 510(k) clearance?

HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls received FDA 510(k) clearance on 2016-07-08, under 510(k) number K153137.

Who is the listed applicant for HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls?

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 HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls?

The FDA product code for HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls is LCO.

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: LCO)

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.

K243374HemosIL CL HIT-IgG(PF4-H)Instrumentation Laboratory (IL) Co.K201570PF4 Enhanced assayImmucor Gti Diagnostics, Inc.K201311PF4 IgG assayImmucor Gti Diagnostics, Inc.K170854HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO

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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