Company ยท US
Intersect Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2002. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 2 |
| DPS | Electrocardiograph | 2 |
| KHS | Enzymatic, Carbon-Dioxide | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHG | Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 |
| CJW | Bromcresol Purple Dye-Binding, Albumin | 1 |
| DQD | Stethoscope, Electronic | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | 1 |
| LBR | Ldl & Vldl Precipitation, Hdl | 1 |
| LPS | Urinary Homocystine (Nonquantitative) Test System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 17, 2002 | K021636 | ALBUMIN REAGENT Intersect Systems, Inc. | CJW |
| Aug 27, 2001 | K011972 | DIRECT BILIRUBIN REAGENT Intersect Systems, Inc. | CIG |
| Jul 25, 2001 | K011692 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT Intersect Systems, Inc. | LPS |
| Feb 20, 2001 | K003892 | TOTAL BILIRUBIN REAGENT Intersect Systems, Inc. | CIG |
| Jan 6, 1999 | K983937 | DUAL VIAL CREATININE REAGENT Intersect Systems, Inc. | CGX |
| Feb 13, 1998 | K974833 | CK-NAC REAGENT Intersect Systems, Inc. | CGS |
| Sep 14, 1994 | K941807 | INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT Intersect Systems, Inc. | CHG |
| Jan 31, 1994 | K932888 | INTERSECT SYSTEMS DIRECT AMYLASE REAGENT Intersect Systems, Inc. | JFJ |
| Nov 16, 1993 | K934039 | INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET Intersect Systems, Inc. | LBR |
| Sep 24, 1993 | K932267 | ENZYMATIC CO2 REAGENT, MODIFICATION Intersect Systems, Inc. | KHS |
| Oct 11, 1991 | K913225 | URINE/CSF MICROPROTEIN REAGENT Intersect Systems, Inc. | CEK |
| Apr 16, 1991 | K911297 | CHLORIDE REAGENT Intersect Systems, Inc. | CHJ |
| Apr 28, 1988 | K881169 | CARBON DIOXIDE REAGENT Intersect Systems, Inc. | KHS |
| Nov 24, 1987 | K873835 | GLUCOSE-HK REAGENT Intersect Systems, Inc. | CFR |
| Jun 11, 1987 | K871979 | GAMMA GLUTAMYLTRANSFERASE REAGENT Intersect Systems, Inc. | JPZ |
| Mar 13, 1987 | K870828 | INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT Intersect Systems, Inc. | CHH |
| Mar 13, 1987 | K870827 | INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT Intersect Systems, Inc. | CDT |
| Mar 6, 1987 | K870616 | GLUCOSE OXIDASE REAGENT Intersect Systems, Inc. | CGA |
| Apr 17, 1984 | K841148 | MINI PECG-MODIFICATION Intersect Systems, Inc. | DPS |
| Dec 6, 1983 | K832883 | MINI-PECG Intersect Systems, Inc. | DPS |
| Dec 6, 1983 | K832882 | DIF-STET Intersect Systems, Inc. | DQD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||