JBX · Class II · 21 CFR 864.6675

FDA Product Code JBX: Aggregrometer, Platelet

Leading manufacturers include Chrono-Log Corp., Bio/Data Corp. and Diagnostica, Inc..

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 Nov 02, 1993
AGGRO/LINK CONTROL SOFTWARE
K932566
Chrono-Log Corp.
Hematology · 159d
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 Jun 12, 1985
AGGRO/LINK COMPUTER INTERFACE
K851025
Chrono-Log Corp.
Hematology · 93d
Cleared May 13, 1985
PLATELET AGGREGATION REAGENT
K850592
Chrono-Log Corp.
Hematology · 87d
Cleared Sep 29, 1983
RISTOCETIN PLATELET AGGREGA-REAGENT TEST
K832929
Sigma Chemical Co.
Chemistry · 36d
Cleared May 16, 1983
PLATELET AGGREGOMETER
K830749
Chrono-Log Corp.
Hematology · 68d
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
Cleared Oct 24, 1978
BUFFER, COLLAGEN REAGENT AND DILUENT
K781710
Diagnostica, Inc.
Hematology · 19d
Cleared Jul 20, 1976
AGGREGOMETER, DUAL CHANNEL PLATELET
K760159
Chrono-Log Corp.
Hematology · 18d

About Product Code JBX - Regulatory Context