GHH · Class II · 21 CFR 864.7320

FDA Product Code GHH: Fibrin Split Products

Leading manufacturers include Roche Diagnostics Corp., American Bioproducts Co. and E.I. Dupont DE Nemours & Co., Inc..

28
Total
28
Cleared
154d
Avg days
1979
Since

FDA 510(k) Cleared Fibrin Split Products Devices (Product Code GHH)

28 devices
1–24 of 28
Cleared Jan 24, 2013
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
K112120
Diazyme Laboratories
Hematology · 549d
Cleared Mar 14, 2007
TINA-QUANT D-DIMER TEST SYSTEM
K062203
Roche Diagnostics Corp.
Hematology · 225d
Cleared Nov 29, 2004
TRIAGE D-DIMER TEST, MODEL 98100
K042890
Biosite Incorporated
Hematology · 41d
Cleared Apr 01, 2003
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
K030740
Roche Diagnostics Corp.
Hematology · 22d
Cleared Aug 07, 2002
MDA D-DIMER
K021877
bioMerieux, Inc.
Hematology · 61d
Cleared May 29, 2001
TINA-QUANT D-DIMER TEST SYSTEM
K011143
Roche Diagnostics Corp.
Hematology · 46d
Cleared Sep 09, 1997
OPUS D-DIMER
K972316
Behring Diagnostics, Inc.
Hematology · 81d
Cleared Nov 03, 1993
FDP - SLIDEX DIRECT
K921989
Biomerieux Vitek, Inc.
Hematology · 554d
Cleared Aug 03, 1989
ABBOTT IMX(TM) D-DIMER
K893961
Abbott Laboratories
Hematology · 63d
Cleared Mar 27, 1989
ABBOTT TESTPACK(TM) D-DIMER
K890422
Abbott Laboratories
Hematology · 60d
Cleared Feb 07, 1989
MODIFIED D-DI-TEST KIT
K890399
American Bioproducts Co.
Hematology · 14d
Cleared Feb 09, 1988
FIBRINOSTICON
K880077
Organon Teknika Corp.
Hematology · 29d
Cleared Jul 06, 1987
DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
K872360
American Dade
Hematology · 18d
Cleared Sep 04, 1986
D-DI TEST KIT
K861973
American Bioproducts Co.
Hematology · 106d
Cleared Oct 10, 1985
FDP ASSAY-20 TEST KIT
K852848
American Bioproducts Co.
Hematology · 97d
Cleared Oct 04, 1985
ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK
K852520
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 109d
Cleared Sep 17, 1985
THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT
K852512
Pacific Hemostasis
Hematology · 97d
Cleared Aug 12, 1985
DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR
K852176
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 84d
Cleared Dec 17, 1981
FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN
K812298
Syn-Kit, Inc.
Immunology · 125d
Cleared Oct 10, 1980
FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP)
K801841
American Hospital Supply Corp.
Hematology · 70d
Cleared Sep 04, 1979
FIBRO-TEC TEST KIT
K791358
Calbiochem-Behring Corp.
Hematology · 42d

About Product Code GHH - Regulatory Context