JPI · Class II · 21 CFR 864.6400

FDA Product Code JPI: Device, Hematocrit Measuring

Leading manufacturers include Abbott Laboratories.

1
Total
1
Cleared
266d
Avg days
2017
Since

List of Device, Hematocrit Measuring devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Aug 22, 2017
i-STAT Hematocrit test with i-STAT Alinity System
K163342
Abbott Laboratories
Hematology · 266d

How to use this database

This page lists all FDA 510(k) submissions for Device, Hematocrit Measuring devices (product code JPI). 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 Hematology FDA review panel. Browse all Hematology devices →