AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT— 510(k) K860663

Name: FDA 510(k) clearance K860663
Creator: U.S. Food and Drug Administration
Published: 1986-04-11

Substantially Equivalent

Amresco, Inc.

FDA 510(k) clearance K860663 for AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT, Substantially Equivalent on 1986-04-11. Applicant: Amresco, Inc.. Device class: 2.

Clearance details

Applicant: Amresco, Inc.
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1986-02-24
Decision date: 1986-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solon, OH, 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
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

More clearances from Amresco, Inc.

view all

K905618 — GGT REAGENT1991-02-26
K904468 — DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/71761991-01-17
K905684 — ALKALINE PHOSPHATASE1990-12-28
K905544 — MAGNESIUM REAGENT1990-12-27
K904004 — AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,71161990-12-11

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