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FDA 510(k)

ASSAY KIT, THROMBO-SCREEN

K-Number: K781880 · 1978-12-04

ApplicantPacific Hemostasis
Decision Date1978-12-04
Product CodeGIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ASSAY KIT, THROMBO-SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Hemostasis. It received FDA 510(k) clearance on 1978-12-04 under 510(k) number K781880. The device is classified under product code GIS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASSAY KIT, THROMBO-SCREEN?

ASSAY KIT, THROMBO-SCREEN is a medical device that received FDA 510(k) clearance on 1978-12-04. The listed applicant is Pacific Hemostasis. The 510(k) number is K781880.

When did ASSAY KIT, THROMBO-SCREEN receive FDA 510(k) clearance?

ASSAY KIT, THROMBO-SCREEN received FDA 510(k) clearance on 1978-12-04, under 510(k) number K781880.

Who is the listed applicant for ASSAY KIT, THROMBO-SCREEN?

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 ASSAY KIT, THROMBO-SCREEN?

The FDA product code for ASSAY KIT, THROMBO-SCREEN is GIS.

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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 400CK992278HEPARIN CONTROL PLASMA LEVEL 1K992279HEPARIN CONTROL PLASMA LEVEL 2K991321PACIFIC HEMOSTASIS THROMBOSCREEN 200

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Related Devices (Code: GIS)

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.

K143470Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control SetDiazyme LaboratoriesK042919FIBROTEK FIBR2 Diagnostics, Inc.K993482K-ASSAY FIBRINOGENKamiya Biomedical Co.K963902QUANTITATIVE FIBRINOGEN ASSAYOrtho Diagnostic Systems, Inc.K941001ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITDiagnostic SpecialtiesK925494BIOMERIEUX HEMOLAB FIBRINOMATBiomerieux Vitek, 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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