Medical Device Manufacturer · US , Austin , TX

Seracare Technology - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1999

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Seracare Technology Immunology ✕

4 devices

1-4 of 4

Cleared Dec 09, 1999

QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3

Immunology · 100d

Cleared Dec 09, 1999

QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2

Immunology · 43d

Cleared Nov 16, 1999

QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3

Immunology · 13d

Cleared Nov 12, 1999

QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3

Immunology · 87d