Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Intersect Systems, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
155 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021636 | ALBUMIN REAGENT | Intersect Systems, Inc. | 2002-07-17 | 61 | 0 |
| K011972 | DIRECT BILIRUBIN REAGENT | Intersect Systems, Inc. | 2001-08-27 | 63 | 0 |
| K011692 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT | Intersect Systems, Inc. | 2001-07-25 | 55 | 1 |
| K003892 | TOTAL BILIRUBIN REAGENT | Intersect Systems, Inc. | 2001-02-20 | 64 | 0 |
| K983937 | DUAL VIAL CREATININE REAGENT | Intersect Systems, Inc. | 1999-01-06 | 62 | 0 |
| K974833 | CK-NAC REAGENT | Intersect Systems, Inc. | 1998-02-13 | 51 | 0 |
| K941807 | INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT | Intersect Systems, Inc. | 1994-09-14 | 155 | 0 |
| K932888 | INTERSECT SYSTEMS DIRECT AMYLASE REAGENT | Intersect Systems, Inc. | 1994-01-31 | 231 | 0 |
| K934039 | INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET | Intersect Systems, Inc. | 1993-11-16 | 90 | 0 |
| K932267 | ENZYMATIC CO2 REAGENT, MODIFICATION | Intersect Systems, Inc. | 1993-09-24 | 163 | 0 |
| K913225 | URINE/CSF MICROPROTEIN REAGENT | Intersect Systems, Inc. | 1991-10-11 | 84 | 0 |
| K911297 | CHLORIDE REAGENT | Intersect Systems, Inc. | 1991-04-16 | 22 | 0 |
| K881169 | CARBON DIOXIDE REAGENT | Intersect Systems, Inc. | 1988-04-28 | 41 | 0 |
| K873835 | GLUCOSE-HK REAGENT | Intersect Systems, Inc. | 1987-11-24 | 64 | 0 |
| K871979 | GAMMA GLUTAMYLTRANSFERASE REAGENT | Intersect Systems, Inc. | 1987-06-11 | 20 | 0 |
| K870828 | INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT | Intersect Systems, Inc. | 1987-03-13 | 10 | 0 |
| K870827 | INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT | Intersect Systems, Inc. | 1987-03-13 | 10 | 0 |
| K870616 | GLUCOSE OXIDASE REAGENT | Intersect Systems, Inc. | 1987-03-06 | 22 | 0 |
| K841148 | MINI PECG-MODIFICATION | Intersect Systems, Inc. | 1984-04-17 | 27 | 0 |
| K832882 | DIF-STET | Intersect Systems, Inc. | 1983-12-06 | 102 | 0 |
| K832883 | MINI-PECG | Intersect Systems, Inc. | 1983-12-06 | 102 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda