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FDA 510(k)

A-FACT, ABNORMAL FACTOR ASSAY CONTROL

K-Number: K945855 · 1995-10-24

ApplicantGeorge King Bio-Medical, Inc.
Decision Date1995-10-24
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

A-FACT, ABNORMAL FACTOR ASSAY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is George King Bio-Medical, Inc.. It received FDA 510(k) clearance on 1995-10-24 under 510(k) number K945855. 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 A-FACT, ABNORMAL FACTOR ASSAY CONTROL?

A-FACT, ABNORMAL FACTOR ASSAY CONTROL is a medical device that received FDA 510(k) clearance on 1995-10-24. The listed applicant is George King Bio-Medical, Inc.. The 510(k) number is K945855.

When did A-FACT, ABNORMAL FACTOR ASSAY CONTROL receive FDA 510(k) clearance?

A-FACT, ABNORMAL FACTOR ASSAY CONTROL received FDA 510(k) clearance on 1995-10-24, under 510(k) number K945855.

Who is the listed applicant for A-FACT, ABNORMAL FACTOR ASSAY CONTROL?

The FDA 510(k) record lists George King Bio-Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A-FACT, ABNORMAL FACTOR ASSAY CONTROL?

The FDA product code for A-FACT, ABNORMAL FACTOR ASSAY CONTROL is GGN.

Related Clinical Trials

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Other records listing George King Bio-Medical, Inc. 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.

K161316George King Coumadin PlasmaK945854B-FACT, BORDERLINE FACTOR ASSAY CONTROLK945857PROTEIN C DEFICIENT PLASMAK945856POSITIVE LUPUS ANTICOAGULANT PLASMA

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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