Intersect Systems, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Intersect Systems, Inc.” (first 1983, latest 2002), across 18 product codes in 2 review panels. Median 510(k) review time under this name: 62 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| DPS | Electrocardiograph | 2 | 2 |
| KHS | Enzymatic, Carbon-Dioxide | 2 | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CHG | Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride | 1 | 1 |
Plus 8 more product codes.
Review panels
- Clinical Chemistry (18)
- Cardiovascular (3)
Most recent Intersect Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021636 | ALBUMIN REAGENT | CJW | 2002-07-17 | 61 |
| K011972 | DIRECT BILIRUBIN REAGENT | CIG | 2001-08-27 | 63 |
| K011692 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT | LPS | 2001-07-25 | 55 |
| K003892 | TOTAL BILIRUBIN REAGENT | CIG | 2001-02-20 | 64 |
| K983937 | DUAL VIAL CREATININE REAGENT | CGX | 1999-01-06 | 62 |
| K974833 | CK-NAC REAGENT | CGS | 1998-02-13 | 51 |
| K941807 | INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT | CHG | 1994-09-14 | 155 |
| K932888 | INTERSECT SYSTEMS DIRECT AMYLASE REAGENT | JFJ | 1994-01-31 | 231 |
| K934039 | INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET | LBR | 1993-11-16 | 90 |
| K932267 | ENZYMATIC CO2 REAGENT, MODIFICATION | KHS | 1993-09-24 | 163 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Intersect Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Intersect Medical Products, Inc. (5 510(k)s)
- Intersect Ent. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intersect Systems, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Intersect Systems, Inc.” (first 1983, latest 2002), across 18 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Intersect Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intersect Systems, Inc. is 62 days.
Which FDA product codes appear under Intersect Systems, Inc.?
The most frequent FDA product codes under this applicant name are CIG (Diazo Colorimetry, Bilirubin, 2); DPS (Electrocardiograph, 2); KHS (Enzymatic, Carbon-Dioxide, 2).
Next steps
- See all 21 Intersect Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CIG, Intersect Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.