# K862156: Asserachrom D-DI Kit

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: Sep 16, 1986 after 103 days
- Product code: DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 864.7320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
33 later devices descend from it; 3 cite it directly.
1 of 34 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K973819: Vidas D-Dimer (DD) Assay (1998), 29 descendants of its own
- K020810: Vidas D-Dimer New (DD2) Assay Model#30 442 (2002), 21 descendants of its own
- K040882: Vidas D-Dimer Exclusion Assay, Model 30 442 (2004), 19 descendants of its own
- K070927: Hemosil D-Dimer HS (2007), 8 descendants of its own
- K022976: Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D (2003), 6 descendants of its own

Source page: https://510kreport.com/device/K862156
Methodology: https://510kreport.com/methodology