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)

GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT

K-Number: K864643 · 1987-04-28

ApplicantPacific Hemostasis
Decision Date1987-04-28
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Hemostasis. It received FDA 510(k) clearance on 1987-04-28 under 510(k) number K864643. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT?

GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT is a medical device that received FDA 510(k) clearance on 1987-04-28. The listed applicant is Pacific Hemostasis. The 510(k) number is K864643.

When did GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT receive FDA 510(k) clearance?

GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT received FDA 510(k) clearance on 1987-04-28, under 510(k) number K864643.

Who is the listed applicant for GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT?

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 GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT?

The FDA product code for GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT is LCP.

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 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 400CK992279HEPARIN CONTROL PLASMA LEVEL 2K992278HEPARIN CONTROL PLASMA LEVEL 1K991321PACIFIC HEMOSTASIS THROMBOSCREEN 200

View all 29 devices →

Related Devices (Code: LCP)

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.

K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical CorporationK231465Q-Pad Test SystemQurasenseK214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies ASK192987Aina HbA1c Monitoring System 2Jana Care, Inc.K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.K183230OneDraw A1C Test SystemDrawbridge Health, Inc.

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.

↑