Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FACTOR VIII REFERENCE PLASMA

K-Number: K880292 · 1988-02-19

ApplicantHelena Laboratories
Decision Date1988-02-19
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FACTOR VIII REFERENCE PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1988-02-19 under 510(k) number K880292. 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 FACTOR VIII REFERENCE PLASMA?

FACTOR VIII REFERENCE PLASMA is a medical device that received FDA 510(k) clearance on 1988-02-19. The listed applicant is Helena Laboratories. The 510(k) number is K880292.

When did FACTOR VIII REFERENCE PLASMA receive FDA 510(k) clearance?

FACTOR VIII REFERENCE PLASMA received FDA 510(k) clearance on 1988-02-19, under 510(k) number K880292.

Who is the listed applicant for FACTOR VIII REFERENCE PLASMA?

The FDA 510(k) record lists Helena Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FACTOR VIII REFERENCE PLASMA?

The FDA product code for FACTOR VIII REFERENCE 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 Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

View all 280 devices →

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 COK102851NOFACT VIIIR2 Diagnostics, Inc.K102908NOFACT IXR2 Diagnostics, Inc.K110237HEMOSIL FACTOR VIII DEFICIENT PLASMAInstrumentation Laboratory COK050661HEMOSIL FACTOR II DEFICIENT PLASMAInstrumentation Laboratory CO

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.

↑