GHH · Class II · 21 CFR 864.7320

FDA Product Code GHH: Fibrin Split Products

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

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 Mar 14, 2007
TINA-QUANT D-DIMER TEST SYSTEM
K062203
Roche Diagnostics Corp.
Hematology · 225d
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 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 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 Oct 04, 1985
ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK
K852520
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 109d
Cleared Aug 12, 1985
DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR
K852176
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 84d

About Product Code GHH - Regulatory Context