GIT · Class II · 21 CFR 864.7925

FDA Product Code GIT: Reagent & Control, Partial Thromboplastin Time

Leading manufacturers include Pacific Hemostasis, Creative Laboratory Products, Inc. and Organon Teknika Corp..

4
Total
4
Cleared
52d
Avg days
1982
Since

FDA 510(k) Cleared Reagent & Control, Partial Thromboplastin Time Devices (Product Code GIT)

4 devices
1–4 of 4
Cleared Aug 17, 1988
PLATELIN(R) EXCEL L
K881999
Organon Teknika Corp.
Hematology · 97d
Cleared Mar 18, 1988
CLP 0.02 M CALCIUM CHLORIDE SOLUTION.
K880711
Creative Laboratory Products, Inc.
Hematology · 25d
Cleared Mar 26, 1982
THROMBOSCREEN
K820450
Pacific Hemostasis
Hematology · 36d

About Product Code GIT - Regulatory Context