Intersect Systems, Inc. - FDA 510(k) Cleared Devices
21
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Intersect Systems, Inc. Chemistry ✕
18 devices
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
CK-NAC REAGENT
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
Cleared
Apr 28, 1988
CARBON DIOXIDE REAGENT
Chemistry
41d
Cleared
Nov 24, 1987
GLUCOSE-HK REAGENT
Chemistry
64d
Cleared
Jun 11, 1987
GAMMA GLUTAMYLTRANSFERASE REAGENT
Chemistry
20d
Cleared
Mar 13, 1987
INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT
Chemistry
10d
Cleared
Mar 13, 1987
INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT
Chemistry
10d
Cleared
Mar 06, 1987
GLUCOSE OXIDASE REAGENT
Chemistry
22d