JBX · Class II · 21 CFR 864.6675

FDA Product Code JBX: Aggregrometer, Platelet

Leading manufacturers include Bio/Data Corp., Sigma Chemical Co. and American Bioproducts 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 Jul 01, 1988
PAT PLATELET AGGREGATION TEST
K881829
Streck Laboratories, Inc.
Hematology · 63d
Cleared Oct 22, 1986
ASSERACHROM B-TG KIT
K862775
American Bioproducts Co.
Hematology · 92d
Cleared Sep 29, 1983
RISTOCETIN PLATELET AGGREGA-REAGENT TEST
K832929
Sigma Chemical Co.
Chemistry · 36d
Cleared Jun 01, 1982
PLATELET AGGREGATION PROFILER #PAP-4
K821005
Bio/Data Corp.
Hematology · 50d
Cleared Jul 27, 1981
ARACHIDONIC ACID
K811290
Bio/Data Corp.
Chemistry · 77d

About Product Code JBX - Regulatory Context