GGN · Class II · 21 CFR 864.5425

FDA Product Code GGN: Plasma, Coagulation Control

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

99
Total
99
Cleared
127d
Avg days
1977
Since
99 devices
73–96 of 99
Cleared Mar 22, 1994
COAGULATION A.R.P.
K933277
Helena Laboratories
Hematology · 264d
Cleared Feb 25, 1993
CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM
K922887
Precision Biologicals, Inc.
Hematology · 254d
Cleared Dec 01, 1992
CLIBRATION PLASMAS
K924404
Behring Diagnostics, Inc.
Hematology · 92d
Cleared Oct 26, 1992
COAG-CONTROL [N] KIT
K922174
American Bioproducts Co.
Hematology · 171d
Cleared Jun 09, 1992
THROMBO-CALIBRATOR KIT
K921344
American Bioproducts Co.
Hematology · 82d
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 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 Jan 30, 1989
COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL)
K884854
Precision Biologicals, Inc.
Hematology · 73d
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 Apr 23, 1984
DIACELIN
K840288
Diatech, Inc.
Hematology · 90d
Cleared Feb 03, 1984
CONTACT-K APTT REAGENT
K834086
Pacific Hemostasis
Microbiology · 67d
Cleared Aug 22, 1977
CI-TROL COAGULATION CONTROLS II & III
K771346
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 33d