GJP · Class II · 21 CFR 864.8625

FDA Product Code GJP: Control, Platelet

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Dade, Baxter Travenol Diagnostics, Inc. and Fisher Scientific Co., LLC.

4
Total
4
Cleared
40d
Avg days
1977
Since

FDA 510(k) Cleared Control, Platelet Devices (Product Code GJP)

4 devices
1–4 of 4
Cleared Mar 21, 1988
MSI-PC
K880608
Medical Specialties, Inc.
Hematology · 38d
Cleared Feb 01, 1983
HEMATOLOGY QUALITY CONTROL MIXTURE
K823930
Fisher Scientific Co., LLC
Hematology · 34d
Cleared Aug 25, 1977
PLATELET CONTROLS NORMAL & ABNORMAL
K771588
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 7d
Cleared Jun 24, 1977
LATELET DETERMIBATION KIT, UL 800
K770655
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 79d

About Product Code GJP - Regulatory Context