ELECSYS CK-MB STAT IMMUNOASSAY— 510(k) K140404

Name: FDA 510(k) clearance K140404
Creator: U.S. Food and Drug Administration
Published: 2014-05-08

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K140404 for ELECSYS CK-MB STAT IMMUNOASSAY, Substantially Equivalent on 2014-05-08. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2014-02-18
Decision date: 2014-05-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JHY

view all

K143720 — Dimension Vista MMB Assay2015-09-18
K130080 — EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL2014-05-13
K132571 — ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY2013-10-18
K070835 — OLYMPUS CK-MB REAGENT2007-06-04
K022757 — SPIFE CK KIT, MODEL 3332, 33332002-10-11

More clearances from Roche Diagnostics

view all

K261686 — Elecsys Phospho-Tau (217P) Plasma2026-08-19
K252323 — cobas pulse blood glucose monitoring system2026-06-12
K252280 — Elecsys Anti-SARS-CoV-2 S2026-04-13
K260046 — Elecsys Anti-HBc II2026-04-07
K260048 — Elecsys Anti-HAV IgM2026-04-07

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