Inbios Intl., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Inbios Intl., Inc.” (first 1999, latest 2004), plus 1 De Novo decision, across 6 product codes in 2 review panels. Median 510(k) review time under this name: 113 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| LOO | Reagent, Leishmanii Serological | 1 | 1 |
| NOP | Elisa, Antibody, West Nile Virus | 1 | 1 |
| OSU | Dengue Serological Reagents | 1 | 0 |
Review panels
- Clinical Chemistry (3)
- Microbiology (3)
Most recent Inbios Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041817 | WEST NILE DETECT IGM ELISA | NOP | 2004-11-19 | 136 |
| K023483 | KALAZAR DETECT | LOO | 2003-05-06 | 201 |
| K001092 | GENERIC BLOOD GLUCOSE TEST STRIP | CGA | 2000-07-26 | 113 |
| K992695 | INSURE PRO TEST | JHI | 1999-10-18 | 68 |
| K991515 | INSURE PREGNANCY TEST | DHA | 1999-05-28 | 28 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN100020 | De Novo | Dengue Serological Reagents | 2011-04-08 |
Recalls
openFDA lists no recalls under a recalling firm named Inbios Intl., 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.
- InBios International, Inc. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Inbios Intl., Inc.?
FDA lists 5 510(k) clearances under the applicant name “Inbios Intl., Inc.” (first 1999, latest 2004), plus 1 De Novo decision, across 6 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 Inbios Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inbios Intl., Inc. is 113 days.
Which FDA product codes appear under Inbios Intl., Inc.?
The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 1); DHA (System, Test, Human Chorionic Gonadotropin, 1); JHI (Visual, Pregnancy Hcg, Prescription Use, 1).
Next steps
- See all 5 Inbios Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Inbios Intl., 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.