PARAMAX CHOLESTEROL REAGENT— 510(k) K964660

Substantially Equivalent

Dade Intl., Inc.

FDA 510(k) clearance K964660 for PARAMAX CHOLESTEROL REAGENT, Substantially Equivalent on 1997-06-04. Applicant: Dade Intl., Inc.. Device class: 1.

Clearance details

Applicant: Dade Intl., Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1996-11-20
Decision date: 1997-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHH

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 Dade Intl., Inc.

K974343 — DADE INNOVIN1998-07-22
K970505 — DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/1997-11-17
K973974 — DADE TRU-LIQUID CARDIAC CONTROL1997-11-06
K973668 — CARDIAC TROPONIN-I (TROP) CALIBRATOR1997-10-20
K972524 — DRIED GRAM-POSITIVE MIC/COMBO PANELS1997-09-08

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