Microchemical Specialities, Co.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Microchemical Specialities, Co.” (first 1980, latest 1982), across 2 product codes in 1 review panel. 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 8 | 8 |
| JSH | Culture Media, Non-Selective And Differential | 1 | 1 |
Review panels
- Microbiology (9)
Most recent Microchemical Specialities, Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823198 | RAPID PRESUMPTIVE IDENT. GPA STREP | JTO | 1982-11-16 | 21 |
| K821992 | ALPHA-TOXIN DISCS | JTO | 1982-10-18 | 103 |
| K811854 | GALACTOSID-ASE TUBES | JTO | 1981-07-16 | 15 |
| K811853 | PHOLPHORYL-ASE TUBES | JTO | 1981-07-16 | 15 |
| K811852 | REDUCT-ASE TUBES | JSH | 1981-07-16 | 15 |
| K801916 | ORNITH-ASE TUBES | JTO | 1980-08-20 | 9 |
| K801915 | ENZYME-ASE I TUBES | JTO | 1980-08-20 | 9 |
| K800816 | HIPPUR-ASE TUBES | JTO | 1980-07-08 | 88 |
| K800579 | BETA-ASE TUBES | JTO | 1980-04-08 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named Microchemical Specialities, Co..
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 Microchemical Specialities, Co.?
FDA lists 9 510(k) clearances under the applicant name “Microchemical Specialities, Co.” (first 1980, latest 1982), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Microchemical Specialities, Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microchemical Specialities, Co. is 15 days.
Which FDA product codes appear under Microchemical Specialities, Co.?
The most frequent FDA product codes under this applicant name are JTO (Discs, Strips And Reagents, Microorganism Differentiation, 8); JSH (Culture Media, Non-Selective And Differential, 1).
Next steps
- See all 9 Microchemical Specialities, Co. clearances with predicates and recalls
- Run predicate analysis for product code JTO, Microchemical Specialities, Co.'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.