JOZ · Class II · 21 CFR 864.5700

FDA Product Code JOZ: System, Automated Platelet Aggregation

Leading manufacturers include Dade Behring, Inc., Aggredyne, Inc. and Fujimori Kogyo, Co., Ltd..

38
Total
38
Cleared
164d
Avg days
1977
Since

FDA 510(k) Cleared System, Automated Platelet Aggregation Devices (Product Code JOZ)

38 devices
1–24 of 38
Cleared Feb 14, 2020
T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01
K191364
Fujimori Kogyo, Co., Ltd.
Hematology · 268d
Cleared Mar 29, 2019
AggreGuide A-100 ADP
K181777
Aggredyne, Inc.
Hematology · 269d
Cleared Jul 21, 2006
DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
K060489
Dade Behring, Inc.
Hematology · 147d
Cleared Jun 21, 2001
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
K002885
Dade Behring, Inc.
Hematology · 279d

About Product Code JOZ - Regulatory Context