GHR · Class II · 21 CFR 864.5700

FDA Product Code GHR: Reagent, Platelet Aggregation

Leading manufacturers include Helena Laboratories.

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 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 Oct 20, 1983
PLATELET AGGREGATION REAGENT SET
K832428
Helena Laboratories
Hematology · 90d

About Product Code GHR - Regulatory Context