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FDA 510(k)

PROTEIN C DEFICIENT PLASMA

K-Number: K945857 · 1995-10-20

ApplicantGeorge King Bio-Medical, Inc.
Decision Date1995-10-20
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PROTEIN C DEFICIENT PLASMA 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 1995-10-20 under 510(k) number K945857. The device is classified under product code GJT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTEIN C DEFICIENT PLASMA?

PROTEIN C DEFICIENT PLASMA is a medical device that received FDA 510(k) clearance on 1995-10-20. The listed applicant is George King Bio-Medical, Inc.. The 510(k) number is K945857.

When did PROTEIN C DEFICIENT PLASMA receive FDA 510(k) clearance?

PROTEIN C DEFICIENT PLASMA received FDA 510(k) clearance on 1995-10-20, under 510(k) number K945857.

Who is the listed applicant for PROTEIN C DEFICIENT PLASMA?

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 PROTEIN C DEFICIENT PLASMA?

The FDA product code for PROTEIN C DEFICIENT PLASMA is GJT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 PlasmaK945855A-FACT, ABNORMAL FACTOR ASSAY CONTROLK945854B-FACT, BORDERLINE FACTOR ASSAY CONTROLK945856POSITIVE LUPUS ANTICOAGULANT PLASMA

Related Devices (Code: GJT)

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.

K222831CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc.K180486HemosIL Factor XII Deficient PlasmaInstrumentation Laboratory COK102908NOFACT IXR2 Diagnostics, Inc.K102851NOFACT VIIIR2 Diagnostics, Inc.K110237HEMOSIL FACTOR VIII DEFICIENT PLASMAInstrumentation Laboratory COK050661HEMOSIL FACTOR II DEFICIENT PLASMAInstrumentation Laboratory CO

Official Source

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