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)

745 GLYCOMAT

K-Number: K933287 · 1993-09-09

ApplicantDrew Scientific , Ltd.
Decision Date1993-09-09
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

745 GLYCOMAT is the device name listed in this FDA 510(k) record. The listed applicant is Drew Scientific , Ltd.. It received FDA 510(k) clearance on 1993-09-09 under 510(k) number K933287. 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 745 GLYCOMAT?

745 GLYCOMAT is a medical device that received FDA 510(k) clearance on 1993-09-09. The listed applicant is Drew Scientific , Ltd.. The 510(k) number is K933287.

When did 745 GLYCOMAT receive FDA 510(k) clearance?

745 GLYCOMAT received FDA 510(k) clearance on 1993-09-09, under 510(k) number K933287.

Who is the listed applicant for 745 GLYCOMAT?

The FDA 510(k) record lists Drew Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 745 GLYCOMAT?

The FDA product code for 745 GLYCOMAT 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 Drew Scientific , Ltd. 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.

K060510DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KITK043378DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KITK012152DS30 HCY BLOOD COLLECTION TUBESK982003DS30 HCY HOMOCYSTEINE ASSAY KITK924496GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KITK920198GLYCOMAT HAEMOGLOBIN ANALYSER

View all 7 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.

↑