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FDA 510(k)

HEMOSIL PROTEIN S ACTIVITY ASSAY

K-Number: K102164 · 2011-03-17

ApplicantInstrumentation Laboratory CO
Decision Date2011-03-17
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOSIL PROTEIN S ACTIVITY ASSAY 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 2011-03-17 under 510(k) number K102164. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOSIL PROTEIN S ACTIVITY ASSAY?

HEMOSIL PROTEIN S ACTIVITY ASSAY is a medical device that received FDA 510(k) clearance on 2011-03-17. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K102164.

When did HEMOSIL PROTEIN S ACTIVITY ASSAY receive FDA 510(k) clearance?

HEMOSIL PROTEIN S ACTIVITY ASSAY received FDA 510(k) clearance on 2011-03-17, under 510(k) number K102164.

Who is the listed applicant for HEMOSIL PROTEIN S ACTIVITY ASSAY?

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 PROTEIN S ACTIVITY ASSAY?

The FDA product code for HEMOSIL PROTEIN S ACTIVITY ASSAY is GGP.

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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.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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Related Devices (Code: GGP)

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.

K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory CompanyK220728vWF AgSiemens Healthcare Diagnostics Products GmbHK214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory COK200033HemosIL von Willebrand Factor AntigenInstrumentation 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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