Product code DAP— Hematology
HEMOSIL D-DIMER
- Classification name
- Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 864.7320
- Advisory panel
- Hematology
- Total cleared
- 58
- First cleared
- Most recent
Market context for product code DAP
FDA has cleared devices under product code DAP between 1986 and 2026, filed by 22 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- 2026
- 2017
- 2016
- 2015
- 2014
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2005
- 2004
- 2003
- 2002
Top applicants under product code DAP
Recent clearances under product code DAP
- K253985 — INNOVANCE® D-Dimer 2.0 (SMN 10873803)
- K172903 — HemosIL D-Dimer HS 500
- K162227 — STA® - Liatest® D-Di
- K160885 — HemosIL D-Dimer HS
- K151534 — HemosIL D-Dimer HS
- K141144 — STA LIATEST D-DI
- K112818 — VIDAS D-DIMER EXCLUSION II (DEX2)
- K110303 — STRATUS CS ACUTE CARE D-DIMER
- K093626 — INNOVANCE D-DIMER, MODEL OPBP09
- K090264 — HEMOSIL D-DIMER HS 500, CONTROLS
- K091916 — INNOVANCE D-DIMER, MODEL OPBP09
- K081732 — INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
- K073042 — HEMOSIL D-DIMER
- K080069 — DIMERTEST
- K070927 — HEMOSIL D-DIMER HS
- K063356 — STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
- K051597 — STRATUS CS D-DIMER
- K050544 — HEMOSIL D-DIMER HS
- K050278 — HEMOSIL D-DIMER
- K042723 — TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300
- K033491 — ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS
- K041438 — ADVANCED D-DIMER ASSAY
- K040437 — TRIAGE PROFILER S.O.B. PANEL
- K040882 — VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442
- K032419 — QUANTEX D-DIMER
- K030328 — VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
- K030687 — K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C
- K022976 — STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
- K022977 — STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
- K020810 — VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
- K012755 — AUTODIMER ASSAY MODEL # 1431
- K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
- K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
- K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
- K002948 — K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
- K002706 — ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI
- K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
- K002642 — MINIQUANT D-DIMER, MODEL 1447
- K000492 — MDA D-DIMER
- K992957 — ADVANCED D-DIMER
- K974596 — DIMERTEST LATEX ASSAY
- K974776 — MDA D-DIMER
- K973819 — VIDAS D-DIMER (DD) ASSAY
- K972696 — IL TEST D-DIMER
- K964728 — STA-LIATEST D-DI TEST KIT
- K964718 — STA D-DI CALIBRATOR KIT
- K943571 — MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS
- K943787 — AURATEK FDP
- K932657 — FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2
- K915698 — FIBRINOSTIKA TDP MICROELISA SYSTEM
- K920943 — FDP PLASMA TEST KIT
- K915203 — D-DIMER WELLCOTEST (HA10)
- K915503 — FIBRINOGEN FDP CONTROL
- K912876 — FIBRINOSTIKA FBDP MICROELISA SYSTEM
- K890189 — AGEN DIMERTEST EIA
- K882944 — DIMERTEST(R) LATEX
- K872195 — DATA-FI DIMERTEST LATEX ASSAY
- K862156 — ASSERACHROM D-DI KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.