IMX CKMB— 510(k) K883013

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K883013 for IMX CKMB, Substantially Equivalent on 1988-08-08. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1988-07-19
Decision date: 1988-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JHY

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
K140404 — ELECSYS CK-MB STAT IMMUNOASSAY2014-05-08
K132571 — ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY2013-10-18
K070835 — OLYMPUS CK-MB REAGENT2007-06-04

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