ENZYMATIC CHOLESTEROL KIT— 510(k) K843222

Name: FDA 510(k) clearance K843222
Creator: U.S. Food and Drug Administration
Published: 1984-09-28

Substantially Equivalent

Livonia Diagnostics, Inc.

FDA 510(k) clearance K843222 for ENZYMATIC CHOLESTEROL KIT, Substantially Equivalent on 1984-09-28. Applicant: Livonia Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Livonia Diagnostics, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1984-08-16
Decision date: 1984-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Livonia Diagnostics, Inc.

view all

K852161 — SERUM IRON/VIBC REAGENT SET1985-06-10
K844283 — SGPT REAGENT SET1984-11-27
K844322 — SGOT REAGENT SET1984-11-27
K844237 — ALKALINE PHOSPHATASE REAGENT SET1984-11-20
K844156 — UREA NITROGEN REAGENT SET1984-11-13

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