Medical Device Manufacturer · US , Chester , NJ

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

10 submissions · 10 cleared · Since 1991

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cirrus Diagnostics, Inc. Chemistry ✕

9 devices

1-9 of 9

Cleared Jun 09, 1992

IMMULITE(R) FSH

Chemistry · 60d

Cleared Mar 11, 1992

Chemistry · 40d

Cleared Jun 20, 1991

IMMULITE(TM) HCG

Chemistry · 59d

Cleared Apr 29, 1991

IMMULITE(TM) T-UPTAKE

Chemistry · 73d

Cleared Apr 16, 1991

IMMULITE(TM) TOTAL T4

Chemistry · 84d

Cleared Mar 06, 1991

CRP LIPID REAGENT TEST PACK

Chemistry · 79d

Cleared Feb 01, 1991

IMMULITE (TM) TOTAL T3

Chemistry · 73d

Cleared Jan 31, 1991

IMMULITE HS-TSH

Chemistry · 35d

Cleared Jan 11, 1991

IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER

Chemistry · 52d