Clin Tech Diagnostics Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Clin Tech Diagnostics Corp.” (first 1980, latest 1982), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 15 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 |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | 2 | 2 |
| DIF | Drug Mixture Control Materials | 1 | 1 |
| DKJ | Colorimetry, Salicylate | 1 | 1 |
| LDP | Colorimetry, Acetaminophen | 1 | 1 |
Review panels
- Clinical Toxicology (3)
- Hematology (2)
Most recent Clin Tech Diagnostics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K821969 | ACETAMINOPHEN STAT-PAK REAGENT SET | LDP | 1982-07-16 | 15 |
| K820076 | GLYCO-SEP REAGENT TEST SET | LCP | 1982-02-12 | 31 |
| K813185 | SALICYLATE STAT-PAK | DKJ | 1981-11-24 | 8 |
| K810235 | ACETAMINOPHEN/SALICYLATE CONTROL | DIF | 1981-02-10 | 13 |
| K802432 | GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT. | LCP | 1980-12-01 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Clin Tech 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Clin Tech Diagnostics Corp.?
FDA lists 5 510(k) clearances under the applicant name “Clin Tech Diagnostics Corp.” (first 1980, latest 1982), across 4 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 Clin Tech Diagnostics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clin Tech Diagnostics Corp. is 15 days.
Which FDA product codes appear under Clin Tech Diagnostics Corp.?
The most frequent FDA product codes under this applicant name are LCP (Assay, Glycosylated Hemoglobin, 2); DIF (Drug Mixture Control Materials, 1); DKJ (Colorimetry, Salicylate, 1).
Next steps
- See all 5 Clin Tech Diagnostics Corp. clearances with predicates and recalls
- Run predicate analysis for product code LCP, Clin Tech 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.