# Spd Swiss Precision Diagnostics GmbH

- Location (FDA's records): Geneva, CH
- FDA decisions: 4 (2021–2024): 4 510(k) clearances
- Product codes: LCX (4)
- 510(k) review time since 2016: median 343 days, against 264 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Church & Dwight Co., Inc.: 2 (https://510kreport.com/company/church-dwight)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)

## Firms that cite its devices most
- Andon Health Co, Ltd.: 1 (https://510kreport.com/company/andon-health)

## Its most-cited devices
- K213379: Clearblue ® Early Pregnancy Test (2022), cited by 1

## Recent decisions
- K240025: Clearblue® Early Detection Pregnancy Test (Jan 31, 2024)
- K213379: Clearblue ® Early Pregnancy Test (Sep 21, 2022)
- K210341: One Step Pregnancy Test (Mar 10, 2022)
- K200913: Clearblue® Early Digital Pregnancy Test (Aug 13, 2021)

Source page: https://510kreport.com/company/spd-swiss-precision-diagnostics