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FDA 510(k)

PROTHROMBIN FREE BEEF PLASMA (PFB)

K-Number: K791023 · 1979-06-28

ApplicantPacific Hemostasis
Decision Date1979-06-28
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PROTHROMBIN FREE BEEF PLASMA (PFB) is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Hemostasis. It received FDA 510(k) clearance on 1979-06-28 under 510(k) number K791023. 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 PROTHROMBIN FREE BEEF PLASMA (PFB)?

PROTHROMBIN FREE BEEF PLASMA (PFB) is a medical device that received FDA 510(k) clearance on 1979-06-28. The listed applicant is Pacific Hemostasis. The 510(k) number is K791023.

When did PROTHROMBIN FREE BEEF PLASMA (PFB) receive FDA 510(k) clearance?

PROTHROMBIN FREE BEEF PLASMA (PFB) received FDA 510(k) clearance on 1979-06-28, under 510(k) number K791023.

Who is the listed applicant for PROTHROMBIN FREE BEEF PLASMA (PFB)?

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 PROTHROMBIN FREE BEEF PLASMA (PFB)?

The FDA product code for PROTHROMBIN FREE BEEF PLASMA (PFB) 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 400CK992278HEPARIN CONTROL PLASMA LEVEL 1K992279HEPARIN CONTROL PLASMA LEVEL 2K991321PACIFIC 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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