# Provalis Diagnostics, Ltd.

- Location (FDA's records): Rockville, MD
- FDA decisions: 3 (2000–2004): 3 510(k) clearances
- Product codes: LCP (3)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Aalto Scientific, Ltd.: 1 (https://510kreport.com/company/aalto-scientific)

## Firms that cite its devices most
- Mec Dynamics Corp: 1 (https://510kreport.com/company/mec-dynamics)
- Wako Chemicals USA, Inc.: 1 (https://510kreport.com/company/wako-chemicals-usa)

## Its most-cited devices
- K041635: G5 I HBA1C Test, G5 II HBA1C Test (2004), cited by 1
- K011933: Glycosal II Hba 1C Test (2001), cited by 1

## Recent decisions
- K041635: G5 I HBA1C Test, G5 II HBA1C Test (Aug 16, 2004)
- K011933: Glycosal II Hba 1C Test (Nov 2, 2001)
- K001392: Glycosal HBA1C Test (Aug 21, 2000)

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