Inverness Medical Innovations, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Inverness Medical Innovations, Inc.” (first 2001, latest 2007), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 40 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Abbott, based on public ownership records.
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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 | 2 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 | 1 |
| NBW | System, Test, Blood Glucose, Over The Counter | 1 | 1 |
| NJV | Test, Albumin Cobalt Binding | 1 | 1 |
Review panels
- Clinical Chemistry (5)
- Hematology (1)
Most recent Inverness Medical Innovations, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071265 | SMARTCHECK INR SYSTEM | JPA | 2007-11-30 | 207 |
| K071587 | ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY | JJX | 2007-07-30 | 49 |
| K060133 | ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET | JJX | 2006-02-16 | 29 |
| K053196 | ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) | NJV | 2005-12-16 | 30 |
| K011479 | ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | CGA | 2001-11-30 | 200 |
| K011616 | INDUO BLOOD GLUCOSE METER | NBW | 2001-06-21 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Inverness Medical Innovations, 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.
- Inverness Medical, Inc. (1 510(k)s)
- Inverness Medical-Biostar, Inc. (1 510(k)s)
- Inverness Medical Professional Diagnostics (1 510(k)s)
- Inverness Medical Professional Diagnostics-Binax (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Inverness Medical Innovations, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Inverness Medical Innovations, Inc.” (first 2001, latest 2007), across 5 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 Inverness Medical Innovations, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inverness Medical Innovations, Inc. is 40 days.
Which FDA product codes appear under Inverness Medical Innovations, Inc.?
The most frequent FDA product codes under this applicant name are JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 2); CGA (Glucose Oxidase, Glucose, 1); JPA (System, Multipurpose For In Vitro Coagulation Studies, 1).
Next steps
- See all 6 Inverness Medical Innovations, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJX, Inverness Medical Innovations, 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.