In Vitro Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “In Vitro Diagnostics, Inc.” (first 1985, latest 1990), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 65 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 |
|---|---|---|---|
| JIS | Calibrator, Primary | 4 | 4 |
| JIX | Calibrator, Multi-Analyte Mixture | 3 | 3 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| GKZ | Counter, Differential Cell | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 | 1 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 1 | 1 |
| KXT | Enzyme Immunoassay, Digoxin | 1 | 1 |
Review panels
- Clinical Chemistry (12)
- Hematology (2)
- Clinical Toxicology (1)
Most recent In Vitro Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896867 | THYROID STIMULATING HORMONE-EIA-XT | JLW | 1990-02-23 | 79 |
| K896866 | LUTEINIZING HORMONE-EIA-XT | CEP | 1990-02-13 | 69 |
| K896863 | DIGOXIN-EIA-XT | KXT | 1990-02-13 | 69 |
| K896865 | VITRO T4-EIA-XT | KLI | 1990-01-30 | 55 |
| K896925 | T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT | KHQ | 1990-01-18 | 37 |
| K896864 | FOLLICLE STIMULATING HORMONE-EIA-XT | CGJ | 1990-01-11 | 36 |
| K873832 | REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 | KRZ | 1987-11-23 | 63 |
| K871188 | LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086 | JIS | 1987-05-28 | 65 |
| K871187 | LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084 | JIS | 1987-05-28 | 65 |
| K871186 | CESIUM DILUENT 1.5 MMOL CS/L #60087 | JIS | 1987-05-28 | 65 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named In Vitro Diagnostics, 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 Diagnostics, Inc.?
FDA lists 15 510(k) clearances under the applicant name “In Vitro Diagnostics, Inc.” (first 1985, latest 1990), across 10 product codes in 3 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 In Vitro Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name In Vitro Diagnostics, Inc. is 65 days.
Which FDA product codes appear under In Vitro Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JIS (Calibrator, Primary, 4); JIX (Calibrator, Multi-Analyte Mixture, 3); CEP (Radioimmunoassay, Luteinizing Hormone, 1).
Next steps
- See all 15 In Vitro Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIS, In Vitro Diagnostics, 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.