FDA 510(k)

TURBOX ANTITHROMBIN III

K-Number: K884144 · 1988-12-20

Decision Date1988-12-20

Product CodeJBQ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

TURBOX ANTITHROMBIN III is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 1988-12-20 under 510(k) number K884144. 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 TURBOX ANTITHROMBIN III?

TURBOX ANTITHROMBIN III is a medical device that received FDA 510(k) clearance on 1988-12-20. The listed applicant is Unipath , Ltd.. The 510(k) number is K884144.

When did TURBOX ANTITHROMBIN III receive FDA 510(k) clearance?

TURBOX ANTITHROMBIN III received FDA 510(k) clearance on 1988-12-20, under 510(k) number K884144.

Who is the listed applicant for TURBOX ANTITHROMBIN III?

The FDA 510(k) record lists Unipath , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TURBOX ANTITHROMBIN III?

The FDA product code for TURBOX ANTITHROMBIN III is JBQ.

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Other records listing Unipath , Ltd. as applicant

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Related Devices (Code: JBQ)

K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbH K081769INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5Siemens Healthcare Diagnostics K070301HEMOSIL ANTITHROMBINInstrumentation Laboratory CO K062431HEMOSIL LIQUID ANTITHROMBINInstrumentation Laboratory CO K043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105Hyphen Biomed K033775HEMOSIL LIQUID ANTITHROMBIN XLInstrumentation 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.