FDA Product Code
FDA Product Code GHH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7320
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K112120 | DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET | Diazyme Laboratories | 2013-01-24 | Traditional | PDF ↗ |
| K072288 | PATHFAST D-DIMER | Mitsubishi Kagaku Iatron | 2009-05-06 | Traditional | PDF ↗ |
| K070453 | OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL | Olympus Life & Material Science Europa GmbH (Irish | 2007-06-11 | Traditional | PDF ↗ |
| K062203 | TINA-QUANT D-DIMER TEST SYSTEM | Roche Diagnostics Corp. | 2007-03-14 | Traditional | PDF ↗ |
| K042890 | TRIAGE D-DIMER TEST, MODEL 98100 | Biosite Incorporated | 2004-11-29 | Traditional | PDF ↗ |
| K030740 | MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM | Roche Diagnostics Corp. | 2003-04-01 | Special | PDF ↗ |
| K021877 | MDA D-DIMER | bioMerieux, Inc. | 2002-08-07 | Traditional | PDF ↗ |
| K011143 | TINA-QUANT D-DIMER TEST SYSTEM | Roche Diagnostics Corp. | 2001-05-29 | Special | PDF ↗ |
| K993276 | SIMPLIFY D-DIMER, MODEL DCGK1 | Agen Biomedical , Ltd. | 1999-12-14 | Traditional | PDF ↗ |
| K972316 | OPUS D-DIMER | Behring Diagnostics, Inc. | 1997-09-09 | Traditional | PDF ↗ |
| K945642 | AGEN DIMERTEST GOLD EIA | Agen Biomedical , Ltd. | 1995-10-25 | Traditional | PDF ↗ |
| K921989 | FDP - SLIDEX DIRECT | Biomerieux Vitek, Inc. | 1993-11-03 | Traditional | PDF ↗ |
| K920668 | MINUTEX D-DIMER LATEX TEST | Biopool AB | 1992-10-16 | Traditional | PDF ↗ |
| K905643 | BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY | Agen Biomedical , Ltd. | 1991-04-12 | Traditional | PDF ↗ |
| K893961 | ABBOTT IMX(TM) D-DIMER | Abbott Laboratories | 1989-08-03 | Traditional | PDF ↗ |
| K890422 | ABBOTT TESTPACK(TM) D-DIMER | Abbott Laboratories | 1989-03-27 | Traditional | PDF ↗ |
| K890399 | MODIFIED D-DI-TEST KIT | American Bioproducts Co. | 1989-02-07 | Traditional | PDF ↗ |
| K880077 | FIBRINOSTICON | Organon Teknika Corp. | 1988-02-09 | Traditional | PDF ↗ |
| K872360 | DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET | American Dade | 1987-07-06 | Traditional | PDF ↗ |
| K861973 | D-DI TEST KIT | American Bioproducts Co. | 1986-09-04 | Traditional | PDF ↗ |
| K852848 | FDP ASSAY-20 TEST KIT | American Bioproducts Co. | 1985-10-10 | Traditional | PDF ↗ |
| K852520 | ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1985-10-04 | Traditional | PDF ↗ |
| K852512 | THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT | Pacific Hemostasis | 1985-09-17 | Traditional | PDF ↗ |
| K852176 | DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1985-08-12 | Traditional | PDF ↗ |
| K842277 | DIMERTEST LATEX | Mabco, Inc. | 1985-04-03 | Traditional | PDF ↗ |
| K812298 | FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN | Syn-Kit, Inc. | 1981-12-17 | Traditional | PDF ↗ |
| K801841 | FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP) | American Hospital Supply Corp. | 1980-10-10 | Traditional | PDF ↗ |
| K791358 | FIBRO-TEC TEST KIT | Calbiochem-Behring Corp. | 1979-09-04 | Traditional | PDF ↗ |
Product code GHH · Class II · Hematology. Data: openFDA.