TRIGLYCERIDE REAGENT (UV)— 510(k) K823709

Substantially Equivalent

Gilford Diagnostics

FDA 510(k) clearance K823709 for TRIGLYCERIDE REAGENT (UV), Substantially Equivalent on 1983-01-07. Applicant: Gilford Diagnostics. Device class: 1.

Clearance details

Applicant: Gilford Diagnostics
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1982-12-09
Decision date: 1983-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDT

K150819 — Triglycerides2015-08-06
K133067 — ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT2013-11-22
K130332 — VITROS CHEMISTRY PRODUCTS TRIG SLIDES2013-05-31
K113830 — VANTERA CLINICAL ANALYZER2012-08-30
K102993 — ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL2011-05-19

More clearances from Gilford Diagnostics

K832094 — BILIRUBIN CALIBRATORS & CONTROL1983-08-11
K831843 — GILCHEM TOTAL BILIRUBIN REAGENT1983-07-18
K831844 — DIRECT BILIRUBIN REAGENT1983-07-18
K822739 — AHBD1982-10-18
K822334 — BILIRUBIN CALIBRATORS1982-09-02

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