# Pearl Diagnostics, Inc.

- Location (FDA's records): Baltimore, MD
- FDA decisions: 1 (2025–2025): 1 510(k) clearance
- Product codes: NOM (1)
- Predicates its devices cite: 1 (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

## Firms whose devices it cites most
- Bio-Rad: 1 (https://510kreport.com/company/bio-rad)

## Recent decisions
- K243496: MycoMEIA Aspergillus Assay (Aug 1, 2025)

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