TOTAL CHOLESTEROL REAGENT SET— 510(k) K855028

Name: FDA 510(k) clearance K855028
Creator: U.S. Food and Drug Administration
Published: 1986-01-28

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K855028 for TOTAL CHOLESTEROL REAGENT SET, Substantially Equivalent on 1986-01-28. Applicant: Sterling Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1985-12-16
Decision date: 1986-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHH

view all

K251091 — Lipids2025-12-30
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 Sterling Diagnostics, Inc.

view all

K921412 — MICROPROTEIN REAGENT SET1993-01-21
K914609 — TRIGLYCERIDES REAGENT SET1991-11-07
K914039 — SODIUM REAGENT SET1991-10-31
K914040 — PHOSPHOLIPID REAGENT SET1991-10-30
K862255 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)1986-07-29

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