# Accriva Diagnostics, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 3 (2019–2023): 3 510(k) clearances
- Product codes: JPA (2), FMK (1)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- International Technidyne Corp.: 6 (https://510kreport.com/company/international-technidyne)

## Its most-cited devices
- K193041: Hemochron Signature Elite (2019), cited by 1

## Recent decisions
- K223352: Tenderfoot (Mar 2, 2023)
- K202101: GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2 (Dec 29, 2021)
- K193041: Hemochron Signature Elite (Nov 22, 2019)

Source page: https://510kreport.com/company/accriva-diagnostics