GGN · Class II · 21 CFR 864.5425

FDA Product Code GGN: Plasma, Coagulation Control

Leading manufacturers include Helena Laboratories, Bio-Rad and Instrumentation Laboratory CO.

99
Total
99
Cleared
127d
Avg days
1977
Since
99 devices
49–72 of 99
Cleared Jul 26, 1990
COAGULATION CONTROL, LEVEL III
K902363
Sigma Chemical Co.
Hematology · 58d
Cleared Jul 03, 1990
ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA
K902210
Ortho Diagnostic Systems, Inc.
Hematology · 48d
Cleared Jan 25, 1990
ROCKET REFERENCE PLASMA, CAT NO. 5188
K900019
Helena Laboratories
Hematology · 23d
Cleared Feb 02, 1989
DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO
K884901
Baxter Healthcare Corp
Hematology · 71d
Cleared Aug 30, 1988
HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II
K882480
International Technidyne Corp.
Hematology · 75d
Cleared Aug 30, 1988
HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II
K882481
International Technidyne Corp.
Hematology · 75d
Cleared May 02, 1988
VERIFY(R) REFERENCE PLASMA
K881348
Organon Teknika Corp.
Hematology · 33d
Cleared Aug 22, 1977
CI-TROL COAGULATION CONTROLS II & III
K771346
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 33d