FDA 510(k)

ANTITHROMBIN III SCREEN KIT

K-Number: K812215 · 1981-09-01

Decision Date1981-09-01

Product CodeJBQ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

ANTITHROMBIN III SCREEN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Hemostasis. It received FDA 510(k) clearance on 1981-09-01 under 510(k) number K812215. 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 ANTITHROMBIN III SCREEN KIT?

ANTITHROMBIN III SCREEN KIT is a medical device that received FDA 510(k) clearance on 1981-09-01. The listed applicant is Pacific Hemostasis. The 510(k) number is K812215.

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

ANTITHROMBIN III SCREEN KIT received FDA 510(k) clearance on 1981-09-01, under 510(k) number K812215.

Who is the listed applicant for ANTITHROMBIN III SCREEN KIT?

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

What is the FDA product code for ANTITHROMBIN III SCREEN KIT?

The FDA product code for ANTITHROMBIN III SCREEN KIT is JBQ.

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Other records listing Pacific Hemostasis as applicant

K000679THROMBOSTRATE CONTROL PLASMAS K994100PACIFIC HEMOSTASIS THROMBOPLASTIN D K992130PACIFIC HEMOSTASIS THROMBOSCREEN 400C K992279HEPARIN CONTROL PLASMA LEVEL 2 K992278HEPARIN CONTROL PLASMA LEVEL 1 K991321PACIFIC HEMOSTASIS THROMBOSCREEN 200

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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.