Intersect Systems, Inc.
Longview, WA, US
Intersect Systems, Inc. appears in FDA device records in Longview, WA. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Intersect Systems, Inc. between 1983 and 2002. The busiest year on record is 1987, with 5. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 2 |
| 1984 | 1 |
| 1987 | 5 |
| 1988 | 1 |
| 1991 | 2 |
| 1993 | 2 |
| 1994 | 2 |
| 1998 | 1 |
| 1999 | 1 |
| 2001 | 3 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K021636 | ALBUMIN REAGENT | CJW | Substantially Equivalent | |
| K011972 | DIRECT BILIRUBIN REAGENT | CIG | Substantially Equivalent | |
| K011692 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT | LPS | Substantially Equivalent | |
| K003892 | TOTAL BILIRUBIN REAGENT | CIG | Substantially Equivalent | |
| K983937 | DUAL VIAL CREATININE REAGENT | CGX | Substantially Equivalent | |
| K974833 | CK-NAC REAGENT | CGS | Substantially Equivalent | |
| K941807 | INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT | CHG | Substantially Equivalent | |
| K932888 | INTERSECT SYSTEMS DIRECT AMYLASE REAGENT | JFJ | Substantially Equivalent | |
| K934039 | INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET | LBR | Substantially Equivalent | |
| K932267 | ENZYMATIC CO2 REAGENT, MODIFICATION | KHS | Substantially Equivalent | |
| K913225 | URINE/CSF MICROPROTEIN REAGENT | CEK | Substantially Equivalent | |
| K911297 | CHLORIDE REAGENT | CHJ | Substantially Equivalent | |
| K881169 | CARBON DIOXIDE REAGENT | KHS | Substantially Equivalent | |
| K873835 | GLUCOSE-HK REAGENT | CFR | Substantially Equivalent | |
| K871979 | GAMMA GLUTAMYLTRANSFERASE REAGENT | JPZ | Substantially Equivalent | |
| K870828 | INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT | CHH | Substantially Equivalent | |
| K870827 | INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT | CDT | Substantially Equivalent | |
| K870616 | GLUCOSE OXIDASE REAGENT | CGA | Substantially Equivalent | |
| K841148 | MINI PECG-MODIFICATION | DPS | Substantially Equivalent | |
| K832883 | MINI-PECG | DPS | Substantially Equivalent | |
| K832882 | DIF-STET | DQD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CHGAcid, Phosphoric-Tungstic (Spectrophotometric), Chloride
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CEKBiuret (Colorimetric), Total Protein
- CJWBromcresol Purple Dye-Binding, Albumin
- JFJCatalytic Methods, Amylase
- JPZColorimetric Method, Gamma-Glutamyl Transpeptidase
- CIGDiazo Colorimetry, Bilirubin
- DPSElectrocardiograph
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- KHSEnzymatic, Carbon-Dioxide
- CGAGlucose Oxidase, Glucose
- CFRHexokinase, Glucose
- LBRLdl & Vldl Precipitation, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- DQDStethoscope, Electronic
- LPSUrinary Homocystine (Nonquantitative) Test System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain