Advantage Diagnostics Corp.: FDA clearances and approvals
Advantage Diagnostics Corp. has 10 FDA 510(k) clearances (first 1988, latest 2003), across 8 product codes in 4 review panels. Median 510(k) review time: 69 days.
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 |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | 2 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 2 | 2 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| LXQ | Cup, Eye | 1 | 1 |
| MVO | Kit, Test, Multiple, Drugs Of Abuse, Over The Counter | 1 | 1 |
Review panels
Most recent Advantage Diagnostics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023712 | ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST | DKZ | 2003-01-31 | 88 |
| K013778 | PEACE OF MIND HOME DRUG TEST | MVO | 2002-02-07 | 86 |
| K011962 | ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST | DIO | 2001-08-09 | 48 |
| K010921 | ADVANTAGE MARIJUANA (THC) HOME DRUG TEST | LDJ | 2001-06-25 | 90 |
| K003708 | ADVANTAGE THC/COCAINE TEST | DIO | 2001-01-22 | 52 |
| K001567 | ADVANTAGE THC TEST | LDJ | 2000-06-19 | 31 |
| K994227 | ADVANTAGE HCG TEST (URINE/SERUM) | JHI | 2000-02-03 | 50 |
| K991883 | REDI-TEST OPIATES | DJG | 1999-09-15 | 105 |
| K903416 | CANNULA, SURGICAL | GEA | 1990-11-23 | 116 |
| K881369 | ADVANCE DIAGNOSTICS DISPOSABLE EYECUP | LXQ | 1988-05-13 | 42 |
Recalls
openFDA lists no recalls under a recalling firm named Advantage Diagnostics Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Advantage Diagnostics Corp. have?
Advantage Diagnostics Corp. has 10 FDA 510(k) clearances (first 1988, latest 2003), across 8 product codes in 4 review panels.
How long does FDA take to clear Advantage Diagnostics Corp.'s 510(k)s?
The median time from FDA receipt to decision across Advantage Diagnostics Corp.'s cleared 510(k)s is 69 days.
What devices does Advantage Diagnostics Corp. make?
Its most frequent FDA product codes are DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 2); LDJ (Enzyme Immunoassay, Cannabinoids, 2); DJG (Enzyme Immunoassay, Opiates, 1).
Has Advantage Diagnostics Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Advantage Diagnostics Corp. Related entities may recall under other names.
Next steps
- See all 10 Advantage Diagnostics Corp. clearances with predicates and recalls
- Run predicate analysis for product code DIO, Advantage Diagnostics Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.