Mid Tech, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Mid Tech, Inc.” (first 1977, latest 1981), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | 1 |
| JCC | Ph Buffer | 1 | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (3)
- Pathology (1)
Most recent Mid Tech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K810951 | REAGENTS FOR QUANT. ENZYMATIC DETER.-TR. | — | 1981-04-23 | 16 |
| K791869 | GLUCOSE OXIDASE (FRINDER) KIT | CGA | 1979-10-01 | 11 |
| K791313 | ARS, CHEMISTRY | JJY | 1979-08-16 | 35 |
| K771033 | SMAC SYS., SUPPLEMENTAL PRODUCTS FOR | CKA | 1977-08-04 | 56 |
| K770508 | SMAC SYSTEM | JCC | 1977-05-09 | 53 |
Recalls
openFDA lists no recalls under a recalling firm named Mid Tech, 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 Mid Tech, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Mid Tech, Inc.” (first 1977, latest 1981), across 5 product codes in 2 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 Mid Tech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mid Tech, Inc. is 35 days.
Which FDA product codes appear under Mid Tech, Inc.?
The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 1); CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt, 1); JCC (Ph Buffer, 1).
Next steps
- See all 5 Mid Tech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Mid Tech, 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.