JPI · Class II · 21 CFR 864.6400

FDA Product Code JPI: Device, Hematocrit Measuring

Leading manufacturers include Fisher Scientific Co., LLC, Em Diagnostic Systems, Inc. and Abbott Laboratories.

15
Total
15
Cleared
98d
Avg days
1982
Since

FDA 510(k) Cleared Device, Hematocrit Measuring Devices (Product Code JPI)

15 devices
1–15 of 15
Cleared Feb 28, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183680
Abbott Point of Care, Inc.
Hematology · 427d
Cleared Aug 22, 2017
i-STAT Hematocrit test with i-STAT Alinity System
K163342
Abbott Laboratories
Hematology · 266d
Cleared Jul 15, 1985
MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94
K852482
Em Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Mar 24, 1983
MICROHEMATOCRIT READER
K830578
Fisher Scientific Co., LLC
Hematology · 29d
Cleared Jan 21, 1983
MICRO-HEMATOCRIT CENTRIFUGE 335/336
K823558
Fisher Scientific Co., LLC
Hematology · 50d

About Product Code JPI - Regulatory Context