Analytical & Research Chemicals, Inc.: FDA clearances and approvals
Analytical & Research Chemicals, Inc. has 12 FDA 510(k) clearances (first 1978, latest 1983), across 11 product codes in 1 review panel. Median 510(k) review time: 34 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 |
|---|---|---|---|
| CDL | Berthelot Indophenol, Urea Nitrogen | 1 | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGE | Orthotoluidine, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 | 1 |
| CIO | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (10)
Most recent Analytical & Research Chemicals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823806 | DIRECT CREATININE PROCEDURE | CGX | 1983-01-14 | 29 |
| K823786 | ALKALINE PHOSPHATASE | CJE | 1983-01-14 | 29 |
| K823784 | ENZYMATIC CHOLESTEROL (COLORIMETRIC | CHH | 1983-01-14 | 29 |
| K781460 | CHLORIDE REAGENT | CHJ | 1978-10-10 | 50 |
| K781441 | BCG ALBUMIN REAGET | CIX | 1978-10-10 | 50 |
| K781324 | ALP TEST | CIO | 1978-08-31 | 31 |
| K781323 | LDH PROCEDURE | — | 1978-08-31 | 31 |
| K781309 | GOT PROCEDURE | — | 1978-08-31 | 34 |
| K781308 | GLUCOLOUR | CGE | 1978-08-31 | 34 |
| K781307 | GLUCOSE DETERM. KIT | CGA | 1978-08-31 | 34 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Analytical & Research Chemicals, 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 Analytical & Research Chemicals, Inc. have?
Analytical & Research Chemicals, Inc. has 12 FDA 510(k) clearances (first 1978, latest 1983), across 11 product codes in 1 review panel.
How long does FDA take to clear Analytical & Research Chemicals, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Analytical & Research Chemicals, Inc.'s cleared 510(k)s is 34 days.
What devices does Analytical & Research Chemicals, Inc. make?
Its most frequent FDA product codes are CDL (Berthelot Indophenol, Urea Nitrogen, 1); CDW (Diacetyl-Monoxime, Urea Nitrogen, 1); CGA (Glucose Oxidase, Glucose, 1).
Has Analytical & Research Chemicals, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Analytical & Research Chemicals, Inc. Related entities may recall under other names.
Next steps
- See all 12 Analytical & Research Chemicals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDL, Analytical & Research Chemicals, 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.