JOZ · Class II · 21 CFR 864.5700

FDA Product Code JOZ: System, Automated Platelet Aggregation

Leading manufacturers include Helena Laboratories, Dade Behring, Inc. and Bio/Data Corp..

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 Feb 14, 2003
PLATELETWORKS, MODELS PW-A, PW-C
K023761
Helena Laboratories
Hematology · 98d
Cleared Sep 28, 2001
PLATELETWORKS
K012723
Helena Laboratories
Hematology · 44d
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
Cleared Jul 23, 1985
MONITOR IV PLUS
K851669
Helena Laboratories
Hematology · 91d
Cleared Mar 25, 1980
HELENA RISTOCETIN
K800432
Helena Laboratories
Hematology · 27d
Cleared Sep 17, 1979
ELVI 840 AGGREGOMETER
K791577
Volu Sol Medical Industries
Hematology · 31d
Cleared May 03, 1979
BETA/PAK
K790769
Bio/Data Corp.
Hematology · 14d
Cleared Mar 30, 1978
SOLUBLE COLLAGEN
K780285
General Diagnostics
Hematology · 37d
Cleared Mar 02, 1978
PLATELET AGGREGATING REAGENTS
K780047
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 52d
Cleared Jan 12, 1977
AGGRECETIN
K760893
Bio/Data Corp.
Hematology · 77d

About Product Code JOZ - Regulatory Context