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
25–48 of 99
Cleared Mar 22, 1994
COAGULATION A.R.P.
K933277
Helena Laboratories
Hematology · 264d
Cleared Mar 04, 1992
COAGULATION ARPR,CAT.NO.5185
K914949
Helena Laboratories
Hematology · 121d
Cleared Aug 22, 1991
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
K911777
Helena Laboratories
Hematology · 142d
Cleared Feb 11, 1991
AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183
K905673
Helena Laboratories
Hematology · 55d
Cleared Jul 26, 1990
COAGULATION CONTROL, LEVEL I
K902361
Sigma Chemical Co.
Hematology · 58d
Cleared Jul 26, 1990
COAGULATION CONTROL, LEVEL II
K902362
Sigma Chemical Co.
Hematology · 58d
Cleared Jul 26, 1990
COAGULATION CONTROL, LEVEL III
K902363
Sigma Chemical Co.
Hematology · 58d
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