Tech-Neal Scientific, Inc.: FDA clearances and approvals
Tech-Neal Scientific, Inc. has 20 FDA 510(k) clearances (first 1988, latest 1988), across 19 product codes in 1 review panel. Median 510(k) review time: 41 days.
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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 | 1 |
Plus 9 more product codes.
Review panels
- Clinical Chemistry (20)
Most recent Tech-Neal Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882256 | MAGNESIUM REAGENT SET | JGJ | 1988-08-08 | 69 |
| K882459 | DIAZO, COLORIMETRIC BILIRUBIN | CIG | 1988-08-02 | 48 |
| K881239 | GAMMA GLUTAMYL TRANSFERASE REAGENT SET | JPZ | 1988-05-31 | 70 |
| K881241 | TOTAL BILIRUBIN REAGENT | CIG | 1988-05-27 | 66 |
| K881240 | CHLORIDE REAGENT SET | CHJ | 1988-04-28 | 37 |
| K881237 | CREATINE KINASE (CK) REAGENT SET | JHX | 1988-04-28 | 37 |
| K880237 | CHOLESTEROL | CHH | 1988-04-28 | 99 |
| K880277 | URIC ACID REAGENT SET | KNK | 1988-04-18 | 88 |
| K880845 | CALCIUM REAGENT SET | CIC | 1988-04-05 | 39 |
| K880844 | ALBUMIN REAGENT SET | CIX | 1988-04-05 | 39 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tech-Neal Scientific, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Tech-Neal Scientific, Inc. have?
Tech-Neal Scientific, Inc. has 20 FDA 510(k) clearances (first 1988, latest 1988), across 19 product codes in 1 review panel.
How long does FDA take to clear Tech-Neal Scientific, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tech-Neal Scientific, Inc.'s cleared 510(k)s is 41 days.
What devices does Tech-Neal Scientific, Inc. make?
Its most frequent FDA product codes are CIG (Diazo Colorimetry, Bilirubin, 2); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 1).
Has Tech-Neal Scientific, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tech-Neal Scientific, Inc. Related entities may recall under other names.
Next steps
- See all 20 Tech-Neal Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CIG, Tech-Neal Scientific, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.