JBX · Class II · 21 CFR 864.6675

FDA Product Code JBX: Aggregrometer, Platelet

Leading manufacturers include Helena Laboratories and Sigma Chemical Co..

12
Total
12
Cleared
68d
Avg days
1976
Since

FDA 510(k) Cleared Aggregrometer, Platelet Devices (Product Code JBX)

12 devices
1–12 of 12
Cleared Aug 22, 1991
ARACHIDONIC ACID
K912774
Helena Laboratories
Hematology · 59d
Cleared Sep 29, 1983
RISTOCETIN PLATELET AGGREGA-REAGENT TEST
K832929
Sigma Chemical Co.
Chemistry · 36d

About Product Code JBX - Regulatory Context