Dynatech Laboratories, Inc.: FDA filings under this applicant name
FDA lists 44 510(k) clearances under the applicant name “Dynatech Laboratories, Inc.” (first 1978, latest 1996), across 13 product codes in 4 review panels. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 15 | 15 |
| JTC | Device, Microtiter Diluting/Dispensing | 12 | 12 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 7 | 7 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 1 | 1 |
| JSE | Culture Media, Multiple Biochemical Test | 1 | 1 |
| JZQ | Plates And Equipment, Radial Immunodiffusion | 1 | 1 |
| KHO | Fluorometer, For Clinical Use | 1 | 1 |
| KIZ | Dish, Tissue Culture | 1 | 1 |
| KJC | Bottle, Roller, Tissue Culture | 1 | 1 |
Plus 3 more product codes.
Review panels
- Clinical Chemistry (25)
- Microbiology (14)
- Pathology (3)
- Immunology (1)
Most recent Dynatech Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962265 | MLX MICROTITER PLATE LUMINOMETER | JSE | 1996-07-25 | 43 |
| K934111 | MR7000 WITH TIME MANAGER SOFTWARE (TMS) | JQP | 1994-11-02 | 456 |
| K943701 | MRX MICROPLATE READER | JJQ | 1994-10-20 | 83 |
| K923456 | MICROLITE MICROTITER PLATE LUMINOMETER ML3000 | JJQ | 1992-10-13 | 91 |
| K915896 | MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI | JJQ | 1992-05-04 | 137 |
| K920888 | MICROLITE MICROTITER PLATE LUMINOMETER ML2200 | KHO | 1992-03-19 | 37 |
| K913590 | MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER | JJQ | 1991-10-25 | 74 |
| K895313 | MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER | JJQ | 1989-10-17 | 49 |
| K894645 | IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM | JTC | 1989-10-17 | 85 |
| K894687 | DYNATECH MR 5000, CATALOG #011-976-0600 | JJQ | 1989-08-31 | 37 |
34 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dynatech Laboratories, 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.
- Dynatech Corp. (27 510(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 Laboratories, Inc.?
FDA lists 44 510(k) clearances under the applicant name “Dynatech Laboratories, Inc.” (first 1978, latest 1996), across 13 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 Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dynatech Laboratories, Inc. is 32 days.
Which FDA product codes appear under Dynatech Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 15); JTC (Device, Microtiter Diluting/Dispensing, 12); JQW (Station, Pipetting And Diluting, For Clinical Use, 7).
Next steps
- See all 44 Dynatech Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJQ, Dynatech Laboratories, 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.