Medical Device Manufacturer · US , Mchenry , IL

Intersect Systems, Inc.

21 submissions · 21 cleared · Since 1983
21
Total
21
Cleared
0
Denied

Intersect Systems, Inc. — FDA 510(k) Submissions

Intersect Systems, Inc. has submitted 21 FDA 510(k) premarket notifications since 1983, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzymatic, Carbon-dioxide, Diazo Colorimetry, Bilirubin, Electrocardiograph, Mercuric Thiocyanate, Colorimetry, Chloride, Urinary Homocystine (nonquantitative) Test System . Use the specialty filter in the sidebar to narrow results.

21 devices
1–21 of 21
ALBUMIN REAGENT
K021636 · CJW Bromcresol Purple... · Chemistry
Jul 2002 61d
DIRECT BILIRUBIN REAGENT
K011972 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Aug 2001 63d
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
K011692 · LPS Urinary Homocystine... · Chemistry
Jul 2001 55d
TOTAL BILIRUBIN REAGENT
K003892 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Feb 2001 64d
DUAL VIAL CREATININE REAGENT
K983937 · CGX Alkaline Picrate,... · Chemistry
Jan 1999 62d
CK-NAC REAGENT
K974833 · CGS Nad Reduction/nadh... · Chemistry
Feb 1998 51d
INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT
K941807 · CHG Acid, Phosphoric-tungstic... · Chemistry
Sep 1994 155d
INTERSECT SYSTEMS DIRECT AMYLASE REAGENT
K932888 · JFJ Catalytic Methods, Amylase · Chemistry
Jan 1994 231d
INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET
K934039 · LBR Ldl & Vldl Precipitation,... · Chemistry
Nov 1993 90d
ENZYMATIC CO2 REAGENT, MODIFICATION
K932267 · KHS Enzymatic, Carbon-dioxide · Chemistry
Sep 1993 163d
URINE/CSF MICROPROTEIN REAGENT
K913225 · CEK Biuret (colorimetric),... · Chemistry
Oct 1991 84d
CHLORIDE REAGENT
K911297 · CHJ Mercuric Thiocyanate,... · Chemistry
Apr 1991 22d
CARBON DIOXIDE REAGENT
K881169 · KHS Enzymatic, Carbon-dioxide · Chemistry
Apr 1988 41d
GLUCOSE-HK REAGENT
K873835 · CFR Hexokinase, Glucose · Chemistry
Nov 1987 64d
GAMMA GLUTAMYLTRANSFERASE REAGENT
K871979 · JPZ Colorimetric Method,... · Chemistry
Jun 1987 20d
INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT
K870827 · CDT Lipase... · Chemistry
Mar 1987 10d
INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT
K870828 · CHH Enzymatic... · Chemistry
Mar 1987 10d
GLUCOSE OXIDASE REAGENT
K870616 · CGA Glucose Oxidase, Glucose · Chemistry
Mar 1987 22d
MINI PECG-MODIFICATION
K841148 · DPS Electrocardiograph · Cardiovascular
Apr 1984 27d
DIF-STET
K832882 · DQD Stethoscope, Electronic · Cardiovascular
Dec 1983 102d
MINI-PECG
K832883 · DPS Electrocardiograph · Cardiovascular
Dec 1983 102d
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