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FDA 510(k)

THROMBOSCREEN THROMBOPLASTIN-DS

K-Number: K940082 · 1995-02-14

ApplicantPacific Hemostasis
Decision Date1995-02-14
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBOSCREEN THROMBOPLASTIN-DS is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Hemostasis. It received FDA 510(k) clearance on 1995-02-14 under 510(k) number K940082. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBOSCREEN THROMBOPLASTIN-DS?

THROMBOSCREEN THROMBOPLASTIN-DS is a medical device that received FDA 510(k) clearance on 1995-02-14. The listed applicant is Pacific Hemostasis. The 510(k) number is K940082.

When did THROMBOSCREEN THROMBOPLASTIN-DS receive FDA 510(k) clearance?

THROMBOSCREEN THROMBOPLASTIN-DS received FDA 510(k) clearance on 1995-02-14, under 510(k) number K940082.

Who is the listed applicant for THROMBOSCREEN THROMBOPLASTIN-DS?

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 THROMBOSCREEN THROMBOPLASTIN-DS?

The FDA product code for THROMBOSCREEN THROMBOPLASTIN-DS is GJS.

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Other records listing Pacific Hemostasis 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.

K000679THROMBOSTRATE CONTROL PLASMASK994100PACIFIC HEMOSTASIS THROMBOPLASTIN DK992130PACIFIC HEMOSTASIS THROMBOSCREEN 400CK992279HEPARIN CONTROL PLASMA LEVEL 2K992278HEPARIN CONTROL PLASMA LEVEL 1K991321PACIFIC HEMOSTASIS THROMBOSCREEN 200

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Related Devices (Code: GJS)

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.

K253188CoaguChek XS Plus SystemRoche DiagnosticsK251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott LaboratoriesK231711microINR SystemIline Microsystems, S.L.

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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