Macomb Chemical Co.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Macomb Chemical Co.” (first 1977, latest 1983), across 16 product codes in 2 review panels. Median 510(k) review time under this name: 40 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 4 | 4 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 | 3 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | 1 |
Plus 6 more product codes.
Review panels
- Clinical Chemistry (20)
- Hematology (1)
Most recent Macomb Chemical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K830095 | RAPID CHEM ANALYZER II | JJF | 1983-01-28 | 17 |
| K823720 | SPECTROPHOTOMETER | JJQ | 1983-01-07 | 28 |
| K810958 | GLYCOHEMOGLOBIN | LCP | 1981-09-16 | 161 |
| K801086 | P-NITROPHENYL PHOSPHATE | — | 1980-05-28 | 21 |
| K800719 | ENZYMATIC UREA NITROGEN REAGENT SET REVI | CDQ | 1980-05-08 | 38 |
| K800720 | MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO | — | 1980-04-21 | 21 |
| K792533 | CREATINE PHOSPHOKINASE (CPK) REAGENT SET | JHW | 1980-01-11 | 35 |
| K792532 | GLUCOSE (HEXOKINASE) REAGENT SET | CFR | 1980-01-11 | 35 |
| K791669 | GLUCOSE OXIDASE REAGENT SET | CGA | 1979-09-24 | 27 |
| K791511 | ENZYMATIC REAGENT SET, 4X250 ML. | CHH | 1979-09-04 | 40 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Macomb Chemical 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Macomb Biotechnology, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Macomb Chemical Co.?
FDA lists 23 510(k) clearances under the applicant name “Macomb Chemical Co.” (first 1977, latest 1983), across 16 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 Macomb Chemical Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Macomb Chemical Co. is 40 days.
Which FDA product codes appear under Macomb Chemical Co.?
The most frequent FDA product codes under this applicant name are CHH (Enzymatic Esterase--Oxidase, Cholesterol, 4); JJY (Multi-Analyte Controls, All Kinds (Assayed), 3); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 2).
Next steps
- See all 23 Macomb Chemical Co. clearances with predicates and recalls
- Run predicate analysis for product code CHH, Macomb Chemical 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.