JHX

Fluorometric Method, Cpk Or Isoenzymes

Product code: JHX
Device name: Fluorometric Method, Cpk Or Isoenzymes
Device class: Class 2
21 CFR: 21 CFR 862.1215
Medical specialty: Clinical Chemistry
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (last 3 years): 1
Summaries archived here: 1 (direct download)
510(k) clearances (all years, FDA): 48 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-02-16.

Number	Decision date	Applicant	Device name	Summary
K234005	2024-02-16	Beckman Coulter, Inc.	Access CK-MB	PDF

1 summaries are archived here for direct download.

Official FDA classification page: JHX

Classification and pathway per current FDA publications. Data from openFDA (CC0).