GJR · Class II · 21 CFR 864.8625

FDA Product Code GJR: Control, Red-cell

Leading manufacturers include Streck Laboratories, Inc. and Streck.

5
Total
5
Cleared
104d
Avg days
1990
Since

FDA 510(k) Cleared Control, Red-cell Devices (Product Code GJR)

5 devices
1–5 of 5
Cleared Feb 05, 2008
NRBC-CHEX FOR ADVIA
K080016
Streck
Hematology · 33d
Cleared Feb 09, 2006
NRBC-CHEX FOR LH
K060083
Streck
Hematology · 29d
Cleared Mar 03, 2000
CELL-CHEX
K000076
Streck Laboratories, Inc.
Hematology · 53d
Cleared Mar 09, 1990
RET-CHECK
K900484
Streck Laboratories, Inc.
Hematology · 36d

About Product Code GJR - Regulatory Context