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FDA 510(k)

THROMBOSTRATE CONTROL PLASMAS

K-Number: K000679 · 2000-03-24

ApplicantPacific Hemostasis
Decision Date2000-03-24
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBOSTRATE CONTROL PLASMAS is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Hemostasis. It received FDA 510(k) clearance on 2000-03-24 under 510(k) number K000679. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBOSTRATE CONTROL PLASMAS?

THROMBOSTRATE CONTROL PLASMAS is a medical device that received FDA 510(k) clearance on 2000-03-24. The listed applicant is Pacific Hemostasis. The 510(k) number is K000679.

When did THROMBOSTRATE CONTROL PLASMAS receive FDA 510(k) clearance?

THROMBOSTRATE CONTROL PLASMAS received FDA 510(k) clearance on 2000-03-24, under 510(k) number K000679.

Who is the listed applicant for THROMBOSTRATE CONTROL PLASMAS?

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 THROMBOSTRATE CONTROL PLASMAS?

The FDA product code for THROMBOSTRATE CONTROL PLASMAS is GGN.

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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.

K994100PACIFIC HEMOSTASIS THROMBOPLASTIN DK992130PACIFIC HEMOSTASIS THROMBOSCREEN 400CK992279HEPARIN CONTROL PLASMA LEVEL 2K992278HEPARIN CONTROL PLASMA LEVEL 1K991321PACIFIC HEMOSTASIS THROMBOSCREEN 200K990046PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA

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Related Devices (Code: GGN)

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.

K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLCK163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLCK161316George King Coumadin PlasmaGeorge King Bio-Medical, Inc.K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLCK152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLCK150144VisuCon-F Low Fibrinogen Control PlasmaAffinity Biologicals, Inc.

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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