Product code GHH— Hematology
TINA-QUANT D-DIMER TEST SYSTEM
- Classification name
- Fibrin Split Products
- Device class
- Class 2
- Regulation
- 21 CFR 864.7320
- Advisory panel
- Hematology
- Total cleared
- 28
- First cleared
- Most recent
Market context for product code GHH
FDA has cleared devices under product code GHH between 1979 and 2013, filed by 20 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2013
- 2009
- 2007
- 2004
- 2003
- 2002
- 2001
- 1999
- 1997
- 1995
- 1993
- 1992
- 1991
- 1989
- 1988
Top applicants under product code GHH
Recent clearances under product code GHH
- K112120 — DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
- K072288 — PATHFAST D-DIMER
- K070453 — OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
- K062203 — TINA-QUANT D-DIMER TEST SYSTEM
- K042890 — TRIAGE D-DIMER TEST, MODEL 98100
- K030740 — MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
- K021877 — MDA D-DIMER
- K011143 — TINA-QUANT D-DIMER TEST SYSTEM
- K993276 — SIMPLIFY D-DIMER, MODEL DCGK1
- K972316 — OPUS D-DIMER
- K945642 — AGEN DIMERTEST GOLD EIA
- K921989 — FDP - SLIDEX DIRECT
- K920668 — MINUTEX D-DIMER LATEX TEST
- K905643 — BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY
- K893961 — ABBOTT IMX(TM) D-DIMER
- K890422 — ABBOTT TESTPACK(TM) D-DIMER
- K890399 — MODIFIED D-DI-TEST KIT
- K880077 — FIBRINOSTICON
- K872360 — DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
- K861973 — D-DI TEST KIT
- K852848 — FDP ASSAY-20 TEST KIT
- K852520 — ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK
- K852512 — THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT
- K852176 — DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR
- K842277 — DIMERTEST LATEX
- K812298 — FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN
- K801841 — FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP)
- K791358 — FIBRO-TEC TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.