Medical Device Manufacturer · US , Mchenry , IL

Intersect Systems, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1983

21

Total

21

Cleared

0

Denied

FDA 510(k) Regulatory Record - Intersect Systems, Inc. Chemistry ✕

18 devices

1-12 of 18

Cleared Jul 17, 2002

ALBUMIN REAGENT

Chemistry · 61d

Cleared Aug 27, 2001

DIRECT BILIRUBIN REAGENT

Chemistry · 63d

Cleared Jul 25, 2001

HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT

Chemistry · 55d

Cleared Feb 20, 2001

TOTAL BILIRUBIN REAGENT

Chemistry · 64d

Cleared Jan 06, 1999

DUAL VIAL CREATININE REAGENT

Chemistry · 62d

Cleared Feb 13, 1998

Chemistry · 51d

Cleared Sep 14, 1994

INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT

Chemistry · 155d

Cleared Jan 31, 1994

INTERSECT SYSTEMS DIRECT AMYLASE REAGENT

Chemistry · 231d

Cleared Nov 16, 1993

INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET

Chemistry · 90d

Cleared Sep 24, 1993

ENZYMATIC CO2 REAGENT, MODIFICATION

Chemistry · 163d

Cleared Oct 11, 1991

URINE/CSF MICROPROTEIN REAGENT

Chemistry · 84d

Cleared Apr 16, 1991

CHLORIDE REAGENT

Chemistry · 22d