Intersect Systems, Inc.
Medical device manufacturer in Longview, WA.
21510(k) clearances
0PMA approvals
0recalls
Device types
- DPS Electrocardiograph 2
- CIG Diazo Colorimetry, Bilirubin 2
- KHS Enzymatic, Carbon-Dioxide 2
- CJW Bromcresol Purple Dye-Binding, Albumin 1
- DQD Stethoscope, Electronic 1
- LPS Urinary Homocystine (Nonquantitative) Test… 1
- CGX Alkaline Picrate, Colorimetry, Creatinine 1
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 1
- CHG Acid, Phosphoric-Tungstic (Spectrophotometri… 1
- JFJ Catalytic Methods, Amylase 1
- LBR Ldl & Vldl Precipitation, Hdl 1
- CEK Biuret (Colorimetric), Total Protein 1
- CHJ Mercuric Thiocyanate, Colorimetry, Chloride 1
- CFR Hexokinase, Glucose 1
- JPZ Colorimetric Method, Gamma-Glutamyl… 1
- CHH Enzymatic Esterase--Oxidase, Cholesterol 1
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 1
- CGA Glucose Oxidase, Glucose 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K021636 | Albumin ReagentCJW · Traditional | 07/17/2002SE |
| K011972 | Direct Bilirubin ReagentCIG · Traditional | 08/27/2001SE |
| K011692 | Homogeneous Enzymic Homocysteine ReagentLPS · Traditional | 07/25/2001SE |
| K003892 | Total Bilirubin ReagentCIG · Traditional | 02/20/2001SE |
| K983937 | Dual Vial Creatinine ReagentCGX · Traditional | 01/06/1999SE |
| K974833 | Ck-Nac ReagentCGS · Traditional | 02/13/1998SE |
| K941807 | Intersect Systems' Non-Mercuric Chloride ReagentCHG · Traditional | 09/14/1994SE |
| K932888 | Intersect Systems Direct Amylase ReagentJFJ · Traditional | 01/31/1994SE |
| K934039 | Intersect Systems HDL Cholesterol Reagent SetLBR · Traditional | 11/16/1993SE |
| K932267 | Enzymatic CO2 Reagent, ModificationKHS · Traditional | 09/24/1993SE |
| K913225 | Urine/Csf Microprotein ReagentCEK · Traditional | 10/11/1991SE |
| K911297 | Chloride ReagentCHJ · Traditional | 04/16/1991SE |
| K881169 | Carbon Dioxide ReagentKHS · Traditional | 04/28/1988SE |
| K873835 | Glucose-Hk ReagentCFR · Traditional | 11/24/1987SE |
| K871979 | Gamma Glutamyltransferase ReagentJPZ · Traditional | 06/11/1987SE |
| K870828 | Intersect Systems Enzymatic Cholesterol ReagentCHH · Traditional | 03/13/1987SE |
| K870827 | Intersect Systems Triglyceride-Gpo ReagentCDT · Traditional | 03/13/1987SE |
| K870616 | Glucose Oxidase ReagentCGA · Traditional | 03/06/1987SE |
| K841148 | Mini Pecg-ModificationDPS · Traditional | 04/17/1984SE |
| K832883 | Mini-PecgDPS · Traditional | 12/06/1983SE |
| K832882 | Dif-StetDQD · Traditional | 12/06/1983SE |