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)

GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY

K-Number: K120199 · 2012-10-12

ApplicantBeckman Coulter, Inc.
Decision Date2012-10-12
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2012-10-12 under 510(k) number K120199. 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 GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY?

GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY is a medical device that received FDA 510(k) clearance on 2012-10-12. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K120199.

When did GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY receive FDA 510(k) clearance?

GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY received FDA 510(k) clearance on 2012-10-12, under 510(k) number K120199.

Who is the listed applicant for GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY?

The FDA product code for GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY 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 Beckman Coulter, 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.

K262109Access NT-proBNPK252169Access BNP IIK254059Access anti-HBc IgMK253687Access anti-HBc TotalK251995Access anti-HAV IgMK250588Access Rubella IgG

View all 261 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.

↑