Preventive Diagnostics Corp.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Preventive Diagnostics Corp.” (first 1983, latest 1984), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 54 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 |
|---|---|---|---|
| JTW | System, Transport, Aerobic | 3 | 3 |
| JIS | Calibrator, Primary | 2 | 2 |
| JIX | Calibrator, Multi-Analyte Mixture | 2 | 2 |
| KDT | Container, Specimen Mailer And Storage, Sterile | 2 | 2 |
| LBR | Ldl & Vldl Precipitation, Hdl | 2 | 2 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 2 | 2 |
| LIO | Device, Specimen Collection | 2 | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
| LED | Stains, Chemical Solution | 1 | 1 |
Review panels
- Clinical Chemistry (10)
- Microbiology (5)
- Pathology (3)
Most recent Preventive Diagnostics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K840677 | HDL EZ-TZ3 CHOLESTEROL REAGENT KIT | LBS | 1984-04-13 | 58 |
| K840676 | PDC HDL EZ-SEP CHOLESTEROL REAGENT | LBS | 1984-04-04 | 49 |
| K840991 | PRESERV BUFFERED GLYCEROL SALINE | JTW | 1984-03-23 | 16 |
| K840990 | PRESERV CARY BLAIR TRANSPORT PACK | JTW | 1984-03-23 | 16 |
| K840968 | PRESERV TRANSPORT & CULTURE PACK | JTW | 1984-03-23 | 17 |
| K840278 | HDL CHOLESTEROL CONTROLS-LEVELS | JIX | 1984-03-23 | 60 |
| K840220 | HDL CHOLESTEROL AQUEOUS STANDARDS | JIS | 1984-03-23 | 64 |
| K840219 | TRIGLYCERIDE/CHOLESTEROL AQUEOUS | JIX | 1984-03-23 | 64 |
| K840218 | TRIGLYCERIDE AQUEOUS STANDARDS | JIT | 1984-03-23 | 64 |
| K840217 | CHOLESTEROL AQUEOUS STANDARD | JIS | 1984-03-23 | 64 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Preventive Diagnostics Corp..
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.
- Preventive Care, Inc. (3 510(k)s)
- Preventive Technologies, Inc. (3 510(k)s)
- Preventive Medicine Institute (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Preventive Diagnostics Corp.?
FDA lists 18 510(k) clearances under the applicant name “Preventive Diagnostics Corp.” (first 1983, latest 1984), 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 Preventive Diagnostics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Preventive Diagnostics Corp. is 54 days.
Which FDA product codes appear under Preventive Diagnostics Corp.?
The most frequent FDA product codes under this applicant name are JTW (System, Transport, Aerobic, 3); JIS (Calibrator, Primary, 2); JIX (Calibrator, Multi-Analyte Mixture, 2).
Next steps
- See all 18 Preventive Diagnostics Corp. clearances with predicates and recalls
- Run predicate analysis for product code JTW, Preventive Diagnostics Corp.'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.