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)

THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235

K-Number: K012525 · 2001-10-04

ApplicantThermo Dma, Inc.
Decision Date2001-10-04
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Dma, Inc.. It received FDA 510(k) clearance on 2001-10-04 under 510(k) number K012525. 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 THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235?

THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 is a medical device that received FDA 510(k) clearance on 2001-10-04. The listed applicant is Thermo Dma, Inc.. The 510(k) number is K012525.

When did THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 receive FDA 510(k) clearance?

THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 received FDA 510(k) clearance on 2001-10-04, under 510(k) number K012525.

Who is the listed applicant for THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235?

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

What is the FDA product code for THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235?

The FDA product code for THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 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 Dma, 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.

K022108THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050K012878THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609K012518TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113

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.

↑