FDA Product Code JHX: Fluorometric Method, Cpk Or Isoenzymes
Leading manufacturers include Ortho-Clinical Diagnostics and Beckman Coulter, Inc..
2
Total
2
Cleared
109d
Avg days
2022
Since
List of Fluorometric Method, Cpk Or Isoenzymes devices cleared through 510(k)
2 devices
Cleared
Feb 16, 2024
Access CK-MB
Beckman Coulter, Inc.
Chemistry
59d
Cleared
Jan 28, 2022
VITROS Immunodiagnostic Products CK-MB Reagent Pack
Ortho-Clinical Diagnostics
Chemistry
158d
How to use this database
This page lists all FDA 510(k) submissions for Fluorometric Method, Cpk Or Isoenzymes devices (product code JHX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →