GHH — Fibrin Split Products Class II
FDA Device Classification
Classification Details
- Product Code
- GHH
- Device Class
- Class II
- Regulation Number
- 864.7320
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K112120 | diazyme laboratories | DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET | January 24, 2013 |
| K072288 | mitsubishi kagaku iatron | PATHFAST D-DIMER | May 6, 2009 |
| K070453 | olympus life and material science europa gmbh (irish | OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR30 | June 11, 2007 |
| K062203 | roche diagnostics | TINA-QUANT D-DIMER TEST SYSTEM | March 14, 2007 |
| K042890 | biosite incorporated | TRIAGE D-DIMER TEST, MODEL 98100 | November 29, 2004 |
| K030740 | roche diagnostics | MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM | April 1, 2003 |
| K021877 | biomerieux | MDA D-DIMER | August 7, 2002 |
| K011143 | roche diagnostics | TINA-QUANT D-DIMER TEST SYSTEM | May 29, 2001 |
| K993276 | agen biomedical | SIMPLIFY D-DIMER, MODEL DCGK1 | December 14, 1999 |
| K972316 | behring diagnostics | OPUS D-DIMER | September 9, 1997 |
| K945642 | agen biomedical | AGEN DIMERTEST GOLD EIA | October 25, 1995 |
| K921989 | biomerieux vitek | FDP - SLIDEX DIRECT | November 3, 1993 |
| K920668 | biopool | MINUTEX D-DIMER LATEX TEST | October 16, 1992 |
| K905643 | agen biomedical | BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY | April 12, 1991 |
| K893961 | abbott laboratories | ABBOTT IMX(TM) D-DIMER | August 3, 1989 |
| K890422 | abbott laboratories | ABBOTT TESTPACK(TM) D-DIMER | March 27, 1989 |
| K890399 | american bioproducts | MODIFIED D-DI-TEST KIT | February 7, 1989 |
| K880077 | organon teknika | FIBRINOSTICON | February 9, 1988 |
| K872360 | american dade | DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET | July 6, 1987 |
| K861973 | american bioproducts | D-DI TEST KIT | September 4, 1986 |