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FDA 510(k)

HEMOSIL LIQUID ANTITHROMBIN XL

K-Number: K033775 · 2004-01-02

ApplicantInstrumentation Laboratory CO
Decision Date2004-01-02
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOSIL LIQUID ANTITHROMBIN XL 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 2004-01-02 under 510(k) number K033775. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOSIL LIQUID ANTITHROMBIN XL?

HEMOSIL LIQUID ANTITHROMBIN XL is a medical device that received FDA 510(k) clearance on 2004-01-02. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K033775.

When did HEMOSIL LIQUID ANTITHROMBIN XL receive FDA 510(k) clearance?

HEMOSIL LIQUID ANTITHROMBIN XL received FDA 510(k) clearance on 2004-01-02, under 510(k) number K033775.

Who is the listed applicant for HEMOSIL LIQUID ANTITHROMBIN XL?

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 ANTITHROMBIN XL?

The FDA product code for HEMOSIL LIQUID ANTITHROMBIN XL is JBQ.

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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: JBQ)

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.

K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbHK081769INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5Siemens Healthcare DiagnosticsK070301HEMOSIL ANTITHROMBINInstrumentation Laboratory COK062431HEMOSIL LIQUID ANTITHROMBINInstrumentation Laboratory COK043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105Hyphen BiomedK023991CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50Precision 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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