Medical Device Manufacturer · US , Irvine , CA

Qualisys Diagnostics, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1999

Recent clearances: FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM, QUALISYS PSA IMMUNOASSAY

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Qualisys Diagnostics, Inc. Immunology ✕

2 devices

1-2 of 2

Cleared Jun 28, 2000

FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM

Immunology · 182d

Cleared Jul 08, 1999

QUALISYS PSA IMMUNOASSAY

Immunology · 164d