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)

REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER

K-Number: K760055 · 1976-08-26

ApplicantSmithkline Diagnostics, Inc.
Decision Date1976-08-26
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1976-08-26 under 510(k) number K760055. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER?

REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER is a medical device that received FDA 510(k) clearance on 1976-08-26. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K760055.

When did REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER receive FDA 510(k) clearance?

REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER received FDA 510(k) clearance on 1976-08-26, under 510(k) number K760055.

Who is the listed applicant for REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER?

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

What is the FDA product code for REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER?

The FDA product code for REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER is CFR.

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 Smithkline Diagnostics, 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.

K961062FLEXSURE OBTK960183FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)K934863FLEXSURE HPK880499HEMOCCULT SENSITIVE TESTK875131(SKD) CHOLESTEROL TEST KITK862849HEMOCCULT WIPE TEST

View all 42 devices →

Related Devices (Code: CFR)

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.

K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche DiagnosticsK252357Glucose2Abbott IrelandK220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche DiagnosticsK191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche DiagnosticsK170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott LaboratoriesK153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroup

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.

↑