FDA 510(k)

FIBRINOGEN SCREEN

K-Number: K800826 · 1980-05-30

Decision Date1980-05-30

Product CodeKQJ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

FIBRINOGEN 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 1980-05-30 under 510(k) number K800826. The device is classified under product code KQJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRINOGEN SCREEN?

FIBRINOGEN SCREEN is a medical device that received FDA 510(k) clearance on 1980-05-30. The listed applicant is Pacific Hemostasis. The 510(k) number is K800826.

When did FIBRINOGEN SCREEN receive FDA 510(k) clearance?

FIBRINOGEN SCREEN received FDA 510(k) clearance on 1980-05-30, under 510(k) number K800826.

Who is the listed applicant for FIBRINOGEN 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 FIBRINOGEN SCREEN?

The FDA product code for FIBRINOGEN SCREEN is KQJ.

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Other records listing Pacific Hemostasis as applicant

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

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Related Devices (Code: KQJ)

K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLInstrumentation Laboratory (IL) Co.K073367HEMOSIL FIBRINOGEN-CInstrumentation Laboratory CO K050928DADE THROMBIN REAGENTDade Behring, Inc.K971858SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)Sigma Diagnostics, Inc.K970189FIF TMPanbio, Inc.K965113N-ASSAY TIA FIBRINOGEN TEST KITCrestat Diagnostics, 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.