Mcb Manufacturing Chemists, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Mcb Manufacturing Chemists, Inc.” (first 1979, latest 1980), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 21 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 |
|---|---|---|---|
| IAF | Wright'S Stain | 3 | 3 |
| KEA | Resins, Ion-Exchange | 1 | 1 |
| KEP | Media, Mounting, Oil Soluble | 1 | 1 |
Review panels
- Pathology (4)
- Clinical Toxicology (1)
Most recent Mcb Manufacturing Chemists, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K801212 | WRIGHTS RAPID STAIN | IAF | 1980-05-30 | 10 |
| K800847 | ENTELLAN | KEP | 1980-05-08 | 23 |
| K792026 | WRIGHTS RAPID STAIN | IAF | 1979-11-13 | 35 |
| K791929 | WRIGHTS RAPID STAIN | IAF | 1979-10-11 | 14 |
| K782066 | EXETRELUT | KEA | 1979-01-03 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Mcb Manufacturing Chemists, 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 Mcb Manufacturing Chemists, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Mcb Manufacturing Chemists, Inc.” (first 1979, latest 1980), across 3 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 Mcb Manufacturing Chemists, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mcb Manufacturing Chemists, Inc. is 21 days.
Which FDA product codes appear under Mcb Manufacturing Chemists, Inc.?
The most frequent FDA product codes under this applicant name are IAF (Wright'S Stain, 3); KEA (Resins, Ion-Exchange, 1); KEP (Media, Mounting, Oil Soluble, 1).
Next steps
- See all 5 Mcb Manufacturing Chemists, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IAF, Mcb Manufacturing Chemists, 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.