# Simplicity Diagnostics, Inc.

- Location (FDA's records): Hatboro, PA
- FDA decisions: 5 (1992–1997): 5 510(k) clearances
- Product codes: DHR (1), DCK (1), GTQ (1), MJX (1), KTN (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K970100: Tech Simple Syphilis Positive Serum Control Monitor Ontrak Syphilis Positive Serum Control (Mar 10, 1997)
- K922725: Tech Simple Rheumatoid Factor Serum Control (Oct 5, 1992)
- K922722: Tech Dimple C-Reactive Protein Serum Control (Oct 5, 1992)
- K922726: Tech Simple Infectious Mononucleosis Serum Control (Oct 5, 1992)
- K922723: Tech Simple Antistreptolysin O Aso Serum Control (Sep 18, 1992)

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