Medical Device Manufacturer · US , Rockville , MD

Provalis Diagnostics , Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2000

Recent clearances: G5 I HBA1C TEST, G5 II HBA1C TEST, GLYCOSAL II HBA 1C TEST, GLYCOSAL HBA1C TEST

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Provalis Diagnostics , Ltd. Chemistry ✕

2 devices

1-2 of 2

Cleared Aug 16, 2004

G5 I HBA1C TEST, G5 II HBA1C TEST

Chemistry · 61d

Cleared Nov 02, 2001

GLYCOSAL II HBA 1C TEST

Chemistry · 135d