Medical Device Manufacturer · US , Fallbrook , CA

Cliniqa Corporation - FDA 510(k) Cleared Devices

36 submissions · 36 cleared · Since 2001

Recent clearances: I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2, BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE, CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3

36

Total

36

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cliniqa Corporation Immunology ✕

3 devices

1-3 of 3

Cleared Jul 23, 2003

LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS

Immunology · 64d

Cleared Jan 21, 2003

LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER...

Immunology · 13d

Cleared Nov 20, 2001

LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE

Immunology · 42d