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)

GLYCATED HEMOGLOBIN CONTROLS

K-Number: K940143 · 1994-03-15

ApplicantPrimus Corp.
Decision Date1994-03-15
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCATED HEMOGLOBIN CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Primus Corp.. It received FDA 510(k) clearance on 1994-03-15 under 510(k) number K940143. 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 GLYCATED HEMOGLOBIN CONTROLS?

GLYCATED HEMOGLOBIN CONTROLS is a medical device that received FDA 510(k) clearance on 1994-03-15. The listed applicant is Primus Corp.. The 510(k) number is K940143.

When did GLYCATED HEMOGLOBIN CONTROLS receive FDA 510(k) clearance?

GLYCATED HEMOGLOBIN CONTROLS received FDA 510(k) clearance on 1994-03-15, under 510(k) number K940143.

Who is the listed applicant for GLYCATED HEMOGLOBIN CONTROLS?

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

What is the FDA product code for GLYCATED HEMOGLOBIN CONTROLS?

The FDA product code for GLYCATED HEMOGLOBIN CONTROLS 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 Primus Corp. 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.

K062658PRIMUS A1CARE ASSAYK013787NYCOCARD CRPK014084NYCOCARD CRP CONTROLK994045PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2K992921PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL IIK955283PRIMUS VARIANT SYSTEM PVS99

View all 11 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.

↑