CHOLESTEROL REAGENT— 510(k) K810405

Substantially Equivalent

Gilford Diagnostics

FDA 510(k) clearance K810405 for CHOLESTEROL REAGENT, Substantially Equivalent on 1981-02-26. Applicant: Gilford Diagnostics. Device class: 1.

Clearance details

Applicant: Gilford Diagnostics
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1981-02-18
Decision date: 1981-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHH

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K232404 — CHOLESTEROL; HDL-cholesterol; LDL-cholesterol; TRIGLYCERIDES2024-08-09
K203597 — Cholesterol22022-06-30
K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides2019-03-27
K181373 — Extended Lipid Panel Assay2018-10-18

More clearances from Gilford Diagnostics

K832094 — BILIRUBIN CALIBRATORS & CONTROL1983-08-11
K831843 — GILCHEM TOTAL BILIRUBIN REAGENT1983-07-18
K831844 — DIRECT BILIRUBIN REAGENT1983-07-18
K823709 — TRIGLYCERIDE REAGENT (UV)1983-01-07
K822739 — AHBD1982-10-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.