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)

LABONACHECK A1C

K-Number: K111128 · 2012-09-13

ApplicantCeragem International, Inc.
Decision Date2012-09-13
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LABONACHECK A1C is the device name listed in this FDA 510(k) record. The listed applicant is Ceragem International, Inc.. It received FDA 510(k) clearance on 2012-09-13 under 510(k) number K111128. 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 LABONACHECK A1C?

LABONACHECK A1C is a medical device that received FDA 510(k) clearance on 2012-09-13. The listed applicant is Ceragem International, Inc.. The 510(k) number is K111128.

When did LABONACHECK A1C receive FDA 510(k) clearance?

LABONACHECK A1C received FDA 510(k) clearance on 2012-09-13, under 510(k) number K111128.

Who is the listed applicant for LABONACHECK A1C?

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

What is the FDA product code for LABONACHECK A1C?

The FDA product code for LABONACHECK A1C 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 Ceragem International, 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.

K062476CERAGEM RH1 AUTOMATIC THERMAL MASSAGER

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.

↑