American Research Products Co.: FDA filings under this applicant name
FDA lists 56 510(k) clearances under the applicant name “American Research Products Co.” (first 1981, latest 1995), across 30 product codes in 1 review panel. Median 510(k) review time under this name: 44 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 |
|---|---|---|---|
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 4 | 4 |
| CIG | Diazo Colorimetry, Bilirubin | 4 | 4 |
| JGS | Electrode, Ion Specific, Sodium | 4 | 4 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 3 | 3 |
| CGA | Glucose Oxidase, Glucose | 3 | 3 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 3 | 3 |
| CIC | Cresolphthalein Complexone, Calcium | 3 | 3 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 2 | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 2 | 2 |
| CEM | Electrode, Ion Specific, Potassium | 2 | 2 |
Plus 20 more product codes.
Review panels
- Clinical Chemistry (56)
Most recent American Research Products Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942984 | BUN REAGENT | CDQ | 1995-03-01 | 254 |
| K901527 | BIURET (COLORMETRIC), TOTAL PROTEIN | CEK | 1990-07-19 | 108 |
| K901964 | PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463 | CEO | 1990-05-31 | 30 |
| K901960 | IRON REAGENTS PRODUCT CODES 7725 AND 7726 | JMO | 1990-05-31 | 30 |
| K900827 | COLORIMETRIC CHLORIDE PRODUCT #4314125 | CHI | 1990-05-02 | 70 |
| K901702 | NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522 | CKA | 1990-04-25 | 13 |
| K900667 | AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 | CFJ | 1990-04-19 | 65 |
| K900666 | AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791 | CGX | 1990-04-19 | 65 |
| K900571 | AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) | CIG | 1990-04-16 | 68 |
| K900977 | AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500 | CEO | 1990-04-11 | 39 |
46 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Research Products 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.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
- American Sterilizer Co. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Research Products Co.?
FDA lists 56 510(k) clearances under the applicant name “American Research Products Co.” (first 1981, latest 1995), across 30 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 American Research Products Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Research Products Co. is 44 days.
Which FDA product codes appear under American Research Products Co.?
The most frequent FDA product codes under this applicant name are CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus, 4); CIG (Diazo Colorimetry, Bilirubin, 4); JGS (Electrode, Ion Specific, Sodium, 4).
Next steps
- See all 56 American Research Products Co. clearances with predicates and recalls
- Run predicate analysis for product code CEO, American Research Products 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.