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)

HEMOGLOBIN, TESTING SYSTEM

K-Number: K781851 · 1978-11-07

ApplicantIsolab, Inc.
Decision Date1978-11-07
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN, TESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1978-11-07 under 510(k) number K781851. 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 HEMOGLOBIN, TESTING SYSTEM?

HEMOGLOBIN, TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 1978-11-07. The listed applicant is Isolab, Inc.. The 510(k) number is K781851.

When did HEMOGLOBIN, TESTING SYSTEM receive FDA 510(k) clearance?

HEMOGLOBIN, TESTING SYSTEM received FDA 510(k) clearance on 1978-11-07, under 510(k) number K781851.

Who is the listed applicant for HEMOGLOBIN, TESTING SYSTEM?

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

What is the FDA product code for HEMOGLOBIN, TESTING SYSTEM?

The FDA product code for HEMOGLOBIN, TESTING SYSTEM 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 Isolab, 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.

K951014ISOLAB'S T4 TEST KITK950481NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KITK943547PHENYLALANINE TEST KITK950803ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLEK950415FLUOROSCAN NEONATALK942222QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS

View all 44 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.

↑