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)

HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL

K-Number: K063209 · 2007-03-21

ApplicantThermo Electron OY
Decision Date2007-03-21
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Electron OY. It received FDA 510(k) clearance on 2007-03-21 under 510(k) number K063209. 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 HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL?

HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL is a medical device that received FDA 510(k) clearance on 2007-03-21. The listed applicant is Thermo Electron OY. The 510(k) number is K063209.

When did HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL receive FDA 510(k) clearance?

HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL received FDA 510(k) clearance on 2007-03-21, under 510(k) number K063209.

Who is the listed applicant for HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL?

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

What is the FDA product code for HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL?

The FDA product code for HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL 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 Thermo Electron OY 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.

K063145PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLSK063705LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROLK063131CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLSK063838LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGHK063086TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLSK063150COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL

View all 9 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.

↑