GHH — Fibrin Split Products Class II
FDA product code GHH covers "Fibrin Split Products", a Class II medical device regulated under 21 CFR 864.7320. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |