Dynatech Corp.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Dynatech Corp.” (first 1979, latest 1991), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 23 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 |
|---|---|---|---|
| LIB | Device, General Purpose, Microbiology, Diagnostic | 10 | 10 |
| JTC | Device, Microtiter Diluting/Dispensing | 6 | 6 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 | 2 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 2 | 2 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 1 | 1 |
| JQX | Nephelometer, For Clinical Use | 1 | 1 |
| JRQ | Shaker/Stirrer | 1 | 1 |
| KDT | Container, Specimen Mailer And Storage, Sterile | 1 | 1 |
| KHO | Fluorometer, For Clinical Use | 1 | 1 |
| KIZ | Dish, Tissue Culture | 1 | 1 |
Plus 1 more product codes.
Review panels
- Microbiology (16)
- Clinical Chemistry (8)
- Pathology (2)
- General Hospital (1)
Most recent Dynatech Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K904567 | DYNATECH MR4000 MICROPLATE READER | JJQ | 1991-01-28 | 111 |
| K854604 | AUTO MASH | LIB | 1985-12-06 | 18 |
| K854603 | MULTI MASH 2000 | LIB | 1985-12-06 | 18 |
| K854602 | MINI MASH 2000 | LIB | 1985-12-06 | 18 |
| K832117 | IMMULON SUBSTRATE REMOVAWELL STRIPS | LIB | 1983-08-08 | 39 |
| K823787 | HANDI-WASH | LIB | 1983-03-09 | 83 |
| K823833 | MICRO STIX #011-010-5000 & HOLDER#5100 | LIB | 1983-03-08 | 77 |
| K830200 | MICROELISA MINIREADER II | LBI | 1983-02-16 | 27 |
| K823773 | PROVIAL II #006-010-0201 | KDT | 1983-01-21 | 38 |
| K823557 | REMOVAWELL PLATE LID | LIB | 1982-12-28 | 26 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dynatech 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.
- Dynatech Laboratories, Inc. (44 510(k)s)
- Dynatech Cryomedical Co. (6 510(k)s)
- Dynatech Medical Products (5 510(k)s)
- Dynatech Research & Development Co. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dynatech Corp.?
FDA lists 27 510(k) clearances under the applicant name “Dynatech Corp.” (first 1979, latest 1991), across 11 product codes in 4 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 Dynatech Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dynatech Corp. is 23 days.
Which FDA product codes appear under Dynatech Corp.?
The most frequent FDA product codes under this applicant name are LIB (Device, General Purpose, Microbiology, Diagnostic, 10); JTC (Device, Microtiter Diluting/Dispensing, 6); JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 2).
Next steps
- See all 27 Dynatech Corp. clearances with predicates and recalls
- Run predicate analysis for product code LIB, Dynatech 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.