JFP

Electrode, Ion Specific, Calcium

Product code
JFP
Device name
Electrode, Ion Specific, Calcium
Device class
Class 2
21 CFR
21 CFR 862.1145
Medical specialty
Clinical Chemistry
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
0 (direct download)
510(k) clearances (all years, FDA)
29 (all years; only the last 3 years are listed here)

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

Last three years. Most recent: 2023-10-27.

NumberDecision dateApplicantDevice nameSummary
K2303002023-10-27Abbott Point of Care, Inc.i-STAT CG8+ cartridge with the i-STAT 1 SystemFDA
Official FDA classification page: JFP
Classification and pathway per current FDA publications. Data from openFDA (CC0).