FDA Product Code JHX: Fluorometric Method, Cpk Or Isoenzymes
Leading manufacturers include Ortho-Clinical Diagnostics and Beckman Coulter, Inc..
48
Total
48
Cleared
73d
Avg days
1976
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Fluorometric Method, Cpk Or Isoenzymes Devices (Product Code JHX)
48 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
About Product Code JHX - Regulatory Context
510(k) Submission Activity
48 total 510(k) submissions under product code JHX since 1976, with 48 receiving FDA clearance (average review time: 73 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
JHX devices are reviewed by the Chemistry panel. Browse all Chemistry devices →