NEW ENZYMATIC SINGLE REAGENT FREE CHOL.— 510(k) K822417

Name: FDA 510(k) clearance K822417
Creator: U.S. Food and Drug Administration
Published: 1982-10-21

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K822417 for NEW ENZYMATIC SINGLE REAGENT FREE CHOL., Substantially Equivalent on 1982-10-21. Applicant: Sclavo, Inc.. Device class: 1.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1982-08-11
Decision date: 1982-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, 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 Sclavo, Inc.

view all

K914789 — ELISA CMV IGM1992-03-04
K914852 — ELISA TOXO IGM1992-01-23
K914420 — ELISA RUBELLA IGM1991-12-27
K895943 — NORMAL AND ABNORMAL CONTROL SERA1989-12-27
K895822 — TOTAL BILIRUBIN L.F.1989-11-14

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