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)

GTI-PF4 ELISA

K-Number: K983379 · 1999-03-09

ApplicantGenetic Testing Institute
Decision Date1999-03-09
Product CodeLCO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GTI-PF4 ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Genetic Testing Institute. It received FDA 510(k) clearance on 1999-03-09 under 510(k) number K983379. The device is classified under product code LCO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GTI-PF4 ELISA?

GTI-PF4 ELISA is a medical device that received FDA 510(k) clearance on 1999-03-09. The listed applicant is Genetic Testing Institute. The 510(k) number is K983379.

When did GTI-PF4 ELISA receive FDA 510(k) clearance?

GTI-PF4 ELISA received FDA 510(k) clearance on 1999-03-09, under 510(k) number K983379.

Who is the listed applicant for GTI-PF4 ELISA?

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

What is the FDA product code for GTI-PF4 ELISA?

The FDA product code for GTI-PF4 ELISA is LCO.

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 Genetic Testing Institute 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.

K082205FACTOR VIII ANTIBODY SCREENK071781PF4 IGGK053559PF4 ENHANCED SOLID PHASE ELISAK993553GTI-FVIII INHIBITOR ASSAYK841114ALLO-TYPE HUMAN IMMUNOGLOBULIN-

Related Devices (Code: LCO)

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.

K243374HemosIL CL HIT-IgG(PF4-H)Instrumentation Laboratory (IL) Co.K201570PF4 Enhanced assayImmucor Gti Diagnostics, Inc.K201311PF4 IgG assayImmucor Gti Diagnostics, Inc.K170854HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory COK153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsInstrumentation Laboratory COK071781PF4 IGGGenetic Testing Institute

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.

↑