GHR · Class II · 21 CFR 864.5700

FDA Product Code GHR: Reagent, Platelet Aggregation

Leading manufacturers include Helena Laboratories, Chrono-Log Corp. and Medical Diagnostic Technologies, Inc..

11
Total
11
Cleared
82d
Avg days
1976
Since

FDA 510(k) Cleared Reagent, Platelet Aggregation Devices (Product Code GHR)

11 devices
1–11 of 11
Cleared Feb 23, 2007
PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
K061991
Helena Laboratories
Hematology · 225d
Cleared Sep 08, 1995
ADP REAGENT, MODIFIED
K952252
Helena Laboratories
Hematology · 116d
Cleared Aug 26, 1992
PLATELET AGGREGATION REAGENTS
K922800
Chrono-Log Corp.
Hematology · 77d
Cleared May 20, 1991
EPINEPHRINE REAGENT, CAT. NO. 5367
K910680
Helena Laboratories
Hematology · 94d
Cleared May 20, 1991
COLLAGEN REAGENT CAT. NO. 5368
K910706
Helena Laboratories
Hematology · 89d
Cleared May 20, 1991
ADP REAGENT
K910800
Helena Laboratories
Hematology · 84d
Cleared Mar 19, 1991
PLATELET AGGREGATION REAGENTS
K910286
Medical Diagnostic Technologies, Inc.
Hematology · 56d
Cleared Mar 27, 1990
RISTOCETIN
K900792
Medical Diagnostic Technologies, Inc.
Hematology · 35d
Cleared Oct 20, 1983
PLATELET AGGREGATION REAGENT SET
K832428
Helena Laboratories
Hematology · 90d
Cleared Mar 16, 1982
PLATELET AGGREGOMETERS
K820422
Chrono-Log Corp.
Hematology · 28d
Cleared Jul 19, 1976
KIT, PLATELET AGGREGATION REAGENT (#390)
K760198
Chrono-Log Corp.
Hematology · 13d

About Product Code GHR - Regulatory Context