In Vitro Technologies, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “In Vitro Technologies, Inc.” (first 1987, latest 1992), across 1 product code in 1 review panel. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 7 | 7 |
Review panels
- Immunology (7)
Most recent In Vitro Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K914685 | 866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS | DHB | 1992-09-14 | 332 |
| K904661 | IVT RAST TRACER | DHB | 1990-11-29 | 48 |
| K875329 | IVT CENTRAL ALLERGY SCREEN | DHB | 1988-04-07 | 99 |
| K875328 | IVT WESTERN ALLERGY SCREEN | DHB | 1988-03-23 | 84 |
| K874169 | IVT NORTHEAST ALLERGY SCREEN | DHB | 1988-01-11 | 90 |
| K874168 | IVT SOUTHEAST ALLERGY SCREEN | DHB | 1988-01-11 | 90 |
| K870625 | IVT SOUTHWEST ALLERGY SCREEN | DHB | 1987-05-01 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named In Vitro Technologies, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under In Vitro Technologies, Inc.?
FDA lists 7 510(k) clearances under the applicant name “In Vitro Technologies, Inc.” (first 1987, latest 1992), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by In Vitro Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name In Vitro Technologies, Inc. is 90 days.
Which FDA product codes appear under In Vitro Technologies, Inc.?
The most frequent FDA product codes under this applicant name are DHB (System, Test, Radioallergosorbent (Rast) Immunological, 7).
Next steps
- See all 7 In Vitro Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DHB, In Vitro Technologies, 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.