Cleared Traditional

AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT

K860663 · Amresco, Inc. · Chemistry
Apr 1986
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K860663 is an FDA 510(k) clearance for the AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT, a Colorimetric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHY), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on April 11, 1986, 46 days after receiving the submission on February 24, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K860663 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 1986
Decision Date April 11, 1986
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHY — Colorimetric Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

Similar Devices — JHY Colorimetric Method, Cpk Or Isoenzymes

All 39
Dimension Vista MMB Assay
K143720 · Siemens Healthcare Diagnostics · Sep 2015
EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL
K130080 · Medica Corporation · May 2014
ELECSYS CK-MB STAT IMMUNOASSAY
K140404 · Roche Diagnostics · May 2014
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
K132571 · Roche Diagnostics · Oct 2013
OLYMPUS CK-MB REAGENT
K070835 · Olympus Life & Material Science Europa GmbH (Irish · Jun 2007
SPIFE CK KIT, MODEL 3332, 3333
K022757 · Helena Laboratories · Oct 2002