Panels › Hematology › Product code GHH · Class 2
Fibrin Split Products
Regulation 864.7320
0510(k)s in 12 months (28 all time)
0recalls in 12 months (9 all time)
8recalls that name a 510(k)
Top companies in GHH
| Company | 510(k)s | Recalls |
|---|---|---|
| Agen Biomedical , Ltd. | 3 | 0 |
| American Bioproducts Co. | 3 | 0 |
| Roche Diagnostics Corp. | 3 | 0 |
| Abbott Laboratories | 2 | 0 |
| Alere San Diego, Inc. | 0 | 2 |
| E.I. Dupont DE Nemours & Co., Inc. | 2 | 0 |
| American Dade | 1 | 0 |
| American Hospital Supply Corp. | 1 | 0 |
| BBI SOLUTIONS OEM LTD | 0 | 1 |
| Behring Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 24, 2013 | K112120 | DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET Diazyme Laboratories | GHH |
| May 6, 2009 | K072288 | PATHFAST D-DIMER Mitsubishi Kagaku Iatron | GHH |
| Jun 11, 2007 | K070453 | OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL Olympus Life & Material Science Europa GmbH (Irish | GHH |
| Mar 14, 2007 | K062203 | TINA-QUANT D-DIMER TEST SYSTEM Roche Diagnostics Corp. | GHH |
| Nov 29, 2004 | K042890 | TRIAGE D-DIMER TEST, MODEL 98100 Biosite Incorporated | GHH |
| Apr 1, 2003 | K030740 | MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM Roche Diagnostics Corp. | GHH |
| Aug 7, 2002 | K021877 | MDA D-DIMER bioMerieux, Inc. | GHH |
| May 29, 2001 | K011143 | TINA-QUANT D-DIMER TEST SYSTEM Roche Diagnostics Corp. | GHH |
| Dec 14, 1999 | K993276 | SIMPLIFY D-DIMER, MODEL DCGK1 Agen Biomedical , Ltd., AU | GHH |
| Sep 9, 1997 | K972316 | OPUS D-DIMER Behring Diagnostics, Inc. | GHH |
| Oct 25, 1995 | K945642 | AGEN DIMERTEST GOLD EIA Agen Biomedical , Ltd., AU | GHH |
| Nov 3, 1993 | K921989 | FDP - SLIDEX DIRECT Biomerieux Vitek, Inc. | GHH |
| Oct 16, 1992 | K920668 | MINUTEX D-DIMER LATEX TEST Biopool AB, CA | GHH |
| Apr 12, 1991 | K905643 | BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY Agen Biomedical , Ltd., AU | GHH |
| Aug 3, 1989 | K893961 | ABBOTT IMX(TM) D-DIMER Abbott Laboratories | GHH |
| Mar 27, 1989 | K890422 | ABBOTT TESTPACK(TM) D-DIMER Abbott Laboratories | GHH |
| Feb 7, 1989 | K890399 | MODIFIED D-DI-TEST KIT American Bioproducts Co. | GHH |
| Feb 9, 1988 | K880077 | FIBRINOSTICON Organon Teknika Corp. | GHH |
| Jul 6, 1987 | K872360 | DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET American Dade | GHH |
| Sep 4, 1986 | K861973 | D-DI TEST KIT American Bioproducts Co. | GHH |
| Oct 10, 1985 | K852848 | FDP ASSAY-20 TEST KIT American Bioproducts Co. | GHH |
| Oct 4, 1985 | K852520 | ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. | GHH |
| Sep 17, 1985 | K852512 | THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT Pacific Hemostasis | GHH |
| Aug 12, 1985 | K852176 | DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | GHH |
| Apr 3, 1985 | K842277 | DIMERTEST LATEX Mabco, Inc., AT | GHH |
| Dec 17, 1981 | K812298 | FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN Syn-Kit, Inc. | GHH |
| Oct 10, 1980 | K801841 | FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP) American Hospital Supply Corp. | GHH |
| Sep 4, 1979 | K791358 | FIBRO-TEC TEST KIT Calbiochem-Behring Corp. | GHH |
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