Medical Device Manufacturer · US , Dana Point , CA

Kronus - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1989

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Kronus Immunology ✕

4 devices

1-4 of 4

Cleared Mar 30, 1992

KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT

Immunology · 119d

Cleared Mar 30, 1992

KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT

Immunology · 119d

Cleared Jul 25, 1989

ANTI-THYROGLOBULIN TEST KIT

Immunology · 36d

Cleared Jul 25, 1989

MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)

Immunology · 11d