DMA TOTAL CHOLESTEROL PROCEDURE— 510(k) K946161

Name: FDA 510(k) clearance K946161
Creator: U.S. Food and Drug Administration
Published: 1995-08-23

Substantially Equivalent

Data Medical Associates, Inc.

FDA 510(k) clearance K946161 for DMA TOTAL CHOLESTEROL PROCEDURE, Substantially Equivalent on 1995-08-23. Applicant: Data Medical Associates, Inc.. Device class: 1.

Clearance details

Applicant: Data Medical Associates, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1994-12-19
Decision date: 1995-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TX, 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 Data Medical Associates, Inc.

view all

K993098 — HDL-C/LDL-C CALIBRATOR, MODEL 1913-0031999-10-08
K971113 — DMA TRIGLYCERIDES PROCEDURES1997-05-29
K961919 — DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE1996-07-01
K955302 — SERUM BICARBONATE/CARBON DIOXIDE1996-02-29
K955796 — IRON CALIBRATOR & CALIBRATION VERIFICATION SET1996-02-29

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